Study of Obeticholic Acid (OCA) Evaluating Pharmacokineti... | NCT03633227

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Obeticholic Acid (OCA)	Experimental	Participants will initiate treatment with OCA 5 milligrams (mg) tablets orally once weekly. At Week 12, if there are no safety concerns, the dose will be up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose will be considered. At each titration visit, the participants will start the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration will be OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration will be 48-weeks. Participants, who complete their 48-week treatment, can continue the treatment until all randomized participants complete their 48-week treatment period and the database for that period is locked (total duration: approximately up to 3 years).	Drug: Obeticholic Acid (OCA)
Placebo	Placebo Comparator	Participants will receive OCA matching placebo orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who complete their 48-week treatment, can continue the treatment until all randomized participants complete their 48-week treatment period and the database for that period is locked (total duration: approximately up to 3 years).	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Obeticholic Acid (OCA)	Drug	OCA will be administered per dose and schedule specified in the arm description.	Obeticholic Acid (OCA)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Maximum Observed Concentration (Cmax) of Total OCA at Week 12	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Time to Maximum Concentration (Tmax) of Total OCA at Week 12	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Trough Concentration (Ctrough) of Total OCA at Week 12	Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.	24 hours post-dose at Week 12
Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12
Cmax of Total OCA at Week 18	Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.	Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18
Tmax of Total OCA at Week 18

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15	The MELD scoring system is used to assess the severity of chronic liver disease. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) [total bilirubin (mg/deciliter [dL])] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A definite or probable diagnosis of PBC (consistent with American Association for the Study of Liver Diseases [AASLD] and European Association for the Study of the Liver [EASL] Practice Guidelines, defined as having ≥2 of the following 3 diagnostic factors:
- History of elevated alkaline phosphatase (ALP) levels for at least 6 months
- Positive antimitochondrial antibody (AMA) titer or if AMA negative or low titer (≤1:80), PBC specific antibodies (anti-glycoprotein 210 [GP210] and/or anti-SP100) and/or antibodies against the major M2 components (E2 component of mitochondrial pyruvate dehydrogenase complex [PDC-E2], 2-oxo-glutaric acid dehydrogenase complex)
- Liver biopsy consistent with PBC (collected at any time prior to Screening)
Evidence of cirrhosis including at least one of the following:
- Biopsy results consistent with PBC Stage 4
- Liver stiffness as assessed by Transient Elastography (TE) Median Value ≥16.9 kilopascals (kPa)
- Clinical evidence in the absence of acute liver failure consistent with cirrhosis including: gastroesophageal varices, ascites, radiological evidence of cirrhosis (nodular liver or enlargement of portal vein and splenomegaly)
- Combined low platelet count (<140,000/cubic millimeter [mm^3]) with
  - persistent decrease in serum albumin, or
  - elevation in prothrombin time/international normalized ratio (INR) (not due to antithrombotic agent use), or
  - elevated bilirubin (2*upper limit of normal [ULN])
Satisfy the criteria of the modified Child-Pugh (CP) classification for hepatic impairment during Screening:
- Moderate: CP-B (Scores 7 to 9) or
- Severe: CP-C (Scores 10 to 12)
Model of end-stage liver disease (MELD) score of 6 to 24 at Screening
Taking ursodeoxycholic acid (UDCA) for at least 12 months (stable dose for ≥3 months) prior to Day 1, or unable to tolerate or unresponsive to UDCA (no UDCA for ≥3 months)

Exclusion Criteria:

Non-cirrhotic or cirrhotic CP-A (Mild; Score 5 to 6)
History of liver transplant or organ transplant
History of alcohol or drug abuse within 12 months prior to Screening
Hepatic encephalopathy (as defined by a West Haven score of ≥2
History or presence of other concomitant liver diseases including:
- Hepatitis C virus infection and ribonucleic acid (RNA) positive
- Active hepatitis B infection; however, participants who have seroconverted (hepatitis B surface antigen and hepatitis B e antigen negative) may be included in this study after consultation with the medical monitor
- Primary sclerosing cholangitis
- Alcoholic liver disease
- Definite autoimmune liver disease or overlap hepatitis
- Gilbert's Syndrome
In the opinion of the Investigator, fluctuating or rapidly deteriorating hepatic function prior to randomization

Other inclusion/exclusion criteria may apply.

Name	Affiliation	Role
Steven Shiff, M.D.	Intercept Pharmaceuticals	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Inland Empire Liver Foundation		Rialto	California	92377	United States
University of California, Ddavis Medical Center

PubMed Identifier	Type	Citation	Retractions
19554543	Background	Lindor KD, Gershwin ME, Poupon R, Kaplan M, Bergasa NV, Heathcote EJ; American Association for Study of Liver Diseases. Primary biliary cirrhosis. Hepatology. 2009 Jul;50(1):291-308. doi: 10.1002/hep.22906. No abstract available.
19501929	Background	European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases. J Hepatol. 2009 Aug;51(2):237-67. doi: 10.1016/j.jhep.2009.04.009. Epub 2009 Jun 6. No abstract available.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Placebo	Participants received obeticholic acid (OCA) matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 19, 2020	Jul 7, 2022

Arm/Group Information

ID	Title	Description
BG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
BG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
BG002	Total	Total of all reporting groups

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Maximum Observed Concentration (Cmax) of Total OCA at Week 12

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. Pharmacokinetics (PK) of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.

PK Population: participants who received OCA and had adequate concentration-time profile to characterize OCA and its conjugates and must not have had any major protocol deviations that potentially affect exposure level. Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. No participant started OCA 5 mg twice weekly or 10 mg twice weekly at Week 12.

Posted

Mean

Standard Deviation

nanogram per milliliter (ng/mL)

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG0005 OG0010 OG0020

Title

Denominators

Categories

Title	Measurements
	OG000293± 189

Primary

Time to Maximum Concentration (Tmax) of Total OCA at Week 12

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

Trough Concentration (Ctrough) of Total OCA at Week 12

Ctrough was considered as the concentration at 24-hours post-dose at Week 12. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Area Under the Concentration Versus Time Curve From Zero Time to 24 Hours (AUC0-24h) of Total OCA at Week 12

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

Posted

Mean

Standard Deviation

nanogram*hour per milliliter (ng*h/mL)

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Total OCA at Week 18

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Tmax of Total OCA at Week 18

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Ctrough of Total OCA at Week 18

Ctrough was considered as the concentration at 24-hours post-dose at Week 18. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

AUC0-24h of Total OCA at Week 18

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Total OCA at Week 24

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Total OCA at Week 24

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Total OCA at Week 24

Ctrough was considered as the concentration at 24-hours post-dose at Week 24. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Total OCA at Week 24

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Cmax of Total OCA at Week 30

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Total OCA at Week 30

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Total OCA at Week 30

Ctrough was considered as the concentration at 24-hours post-dose at Week 30. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Total OCA at Week 30

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Cmax of Total OCA at Week 48

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Tmax of Total OCA at Week 48

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Ctrough of Total OCA at Week 48

Ctrough was considered as the concentration at 24-hours post-dose at Week 48. Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

AUC0-24h of Total OCA at Week 48

Total OCA is molar sum of unconjugated OCA, glyco-OCA, and tauro-OCA. AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Unconjugated OCA at Week 12

Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg twice weekly or 10 mg twice weekly at Week 12 are not applicable as no participant started 5 mg twice weekly or 10 mg twice weekly at Week 12.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Unconjugated OCA at Week 12

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Unconjugated OCA at Week 12

Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Unconjugated OCA at Week 12

AUC0-24 was calculated using the linear/linear trapezoidal rule.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

Cmax of Unconjugated OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Unconjugated OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Unconjugated OCA at Week 18

Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Unconjugated OCA at Week 18

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of Unconjugated OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of Unconjugated OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of Unconjugated OCA at Week 24

Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Unconjugated OCA at Week 24

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Cmax of Unconjugated OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of Unconjugated OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of Unconjugated OCA at Week 30

Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Unconjugated OCA at Week 30

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Cmax of Unconjugated OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Unconjugated OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Unconjugated OCA at Week 48

Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

AUC0-24h of Unconjugated OCA at Week 48

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Glyco Conjugate of OCA (Glyco-OCA) at Week 12

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Glyco-OCA at Week 12

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Glyco-OCA at Week 12

Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Glyco-OCA at Week 12

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Metabolite to Parent Ratio of AUC-0-24h (MRAUC) of Glyco-OCA at Week 12

MRAUC was the ratio of AUC0-24h of Glyco-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Metabolite to Parent Ratio of Cmax (MRCmax) of Glyco-OCA at Week 12

MRCmax was the ratio of Cmax of Glyco-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Glyco-OCA, where Cmax is the maximum observed concentration.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Glyco-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Glyco-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Glyco-OCA at Week 18

Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Glyco-OCA at Week 18

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

MRAUC of Glyco-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of Glyco-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Glyco-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of Glyco-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of Glyco-OCA at Week 24

Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Glyco-OCA at Week 24

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

MRAUC of Glyco-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

MRCmax of Glyco-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of Glyco-OCA at Week 30

Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of Glyco-OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of Glyco-OCA at Week 30

Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Glyco-OCA at Week 30

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

MRAUC of Glyco-OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

MRCmax of Glyco-OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of Glyco-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Glyco-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Glyco-OCA at Week 48

Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

AUC0-24h of Glyco-OCA at Week 48

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRAUC of Glyco-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of Glyco-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Tauro Conjugate of OCA (Tauro-OCA) at Week 12

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Tauro-OCA at Week 12

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Tauro-OCA at Week 12

Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Tauro-OCA at Week 12

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

MRAUC of Tauro-OCA at Week 12

MRAUC was the ratio of AUC0-24h of Tauro-OCA (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of Tauro-OCA at Week 12

MRCmax was the ratio of Cmax of Tauro-OCA (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of Tauro-OCA, where Cmax is the maximum observed concentration.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Tauro-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Tauro-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Tauro-OCA at Week 18

Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Tauro-OCA at Week 18

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

MRAUC of Tauro-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of Tauro-OCA at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Tauro-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of Tauro-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of Tauro-OCA at Week 24

Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Tauro-OCA at Week 24

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

MRAUC of Tauro-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

MRCmax of Tauro-OCA at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of Tauro-OCA at Week 30

Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of Tauro-OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of Tauro-OCA at Week 30

Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of Tauro-OCA at Week 30

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

MRAUC of Tauro-OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

MRCmax of Tauro-OCA at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of Tauro-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of Tauro-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of Tauro-OCA at Week 48

Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

AUC0-24h of Tauro-OCA at Week 48

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRAUC of Tauro-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of Tauro-OCA at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of Glucuronide Metabolite of OCA (OCA-glucuronide) at Week 12

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of OCA-glucuronide at Week 12

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of OCA-glucuronide at Week 12

Ctrough was considered as the concentration at 24-hours post-dose at Week 12.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of OCA-glucuronide at Week 12

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units

Primary

MRAUC of OCA-glucuronide at Week 12

MRAUC was the ratio of AUC0-24h of OCA-glucuronide (metabolite) to AUC0-24h of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where AUC0-24 is the area under the plasma concentration time profile from time 0 to 24 hours.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of OCA-glucuronide at Week 12

MRCmax was the ratio of Cmax of OCA-glucuronide (metabolite) to Cmax of OCA (parent drug) * ratio of molecular weight of OCA to molecular weight of OCA-glucuronide, where Cmax is the maximum observed concentration.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 12

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of OCA-glucuronide at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of OCA-glucuronide at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of OCA-glucuronide at Week 18

Ctrough was considered as the concentration at 24-hours post-dose at Week 18.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of OCA-glucuronide at Week 18

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

MRAUC of OCA-glucuronide at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of OCA-glucuronide at Week 18

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 10 mg twice weekly at Week 18 is not applicable as no participant started 10 mg twice weekly at Week 18.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 18

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Cmax of OCA-glucuronide at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of OCA-glucuronide at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of OCA-glucuronide at Week 24

Ctrough was considered as the concentration at 24-hours post-dose at Week 24.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of OCA-glucuronide at Week 24

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

MRAUC of OCA-glucuronide at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of OCA-glucuronide at Week 24

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 24

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of OCA-glucuronide at Week 30

Results of PK were planned to be listed by dose regimen. Participants who received planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Tmax of OCA-glucuronide at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants	OG000

Primary

Ctrough of OCA-glucuronide at Week 30

Ctrough was considered as the concentration at 24-hours post-dose at Week 30.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

AUC0-24h of OCA-glucuronide at Week 30

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

MRAUC of OCA-glucuronide at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of OCA-glucuronide at Week 30

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 30

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

Cmax of OCA-glucuronide at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Tmax of OCA-glucuronide at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Median

Full Range

hours

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts
Participants

Primary

Ctrough of OCA-glucuronide at Week 48

Ctrough was considered as the concentration at 24-hours post-dose at Week 48.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng/mL

24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Units	Counts

Primary

AUC0-24h of OCA-glucuronide at Week 48

AUC0-24h was calculated using the linear/linear trapezoidal rule.

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ng*h/mL

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRAUC of OCA-glucuronide at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

MRCmax of OCA-glucuronide at Week 48

Results of PK were planned to be listed by the dose regimen. Participants in the PK population who received the planned dose regimen and had available data were included in the analysis. Pharmacokinetics of OCA 5 mg once weekly at Week 48 is not applicable as participants received either OCA 5 mg twice daily or 10 mg twice daily and no participant received OCA 5 mg once weekly at Week 48.

Posted

Mean

Standard Deviation

ratio

Pre-dose (30 minutes before administration) and 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, and 24 hours post-dose at Week 48

ID	Title	Description
OG000	OCA 5 mg Once Weekly	Participants received OCA 5 mg tablets orally once weekly.
OG001	OCA 5 mg Twice Weekly	Participants received OCA 5 mg tablets orally twice weekly.
OG002	OCA 10 mg Twice Weekly	Participants received OCA 10 mg tablets orally twice weekly.

Primary

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

An adverse event (AE) was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not related to the study drug.

An SAE was any AE that results in death, was life-threatening, resulted in a persistent or significant disability/incapacity, resulted in in-patient hospitalization or prolonged an existing hospitalization, was a congenital anomaly/birth defect, or was an important medical event that could jeopardize the participant or could have required medical intervention to prevent one of the outcomes listed above.

TEAE was defined as any AE if it met one or more of the following criteria: 1) An AE started on or after the first study drug dose and within 30 days after the last dose of study drug, 2) An AE occurred prior to the first study drug dose that worsens (increase in grade) after the first study drug dose.

The Safety Population included all participants who received at least 1 dose of investigational product (OCA or placebo). Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.

Posted

Count of Participants

Participants

Baseline up to approximately 3 years

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in the Model of End-stage Liver Disease (MELD) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

The MELD scoring system is used to assess the severity of chronic liver disease. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) [total bilirubin (mg/deciliter [dL])] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.

Participants in the ITT population with available data were analyzed. Data were prespecified to be collected per randomization arm (OCA or placebo). Data at the separate dose levels are not available.

Posted

Median

Inter-Quartile Range

score on a scale

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in MELD-Sodium (Na) Score at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

The MELD-Na scoring system is used to assess the severity of chronic liver disease in the participants with an initial MELD(i) score greater than 11. MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and sodium. The MELD-Na score is re-calculated as follows:

MELD-Na = MELD(i) + 1.32*(137-Na) - [0.033*MELD(i)*(137-Na)]. MELD score ranges from 6-40 with higher scores indicating more severe liver disease and a worse outcome.

The MELD(i) score is derived from the participant's serum total bilirubin, serum creatinine, and prothrombin international normalized ratio (INR): 3.78×log normal (ln) [total bilirubin (mg/deciliter [dL])] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43. The MELD score ranges from 6 to 40 with higher scores indicating more severe liver disease and a worse outcome.

Posted

Median

Inter-Quartile Range

score on a scale

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Child-Pugh Score at Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

The Child-Pugh classification was a scoring system used for the classification of the severity of cirrhosis. It included three continuous variables (bilirubin, albumin, and INR) and two discrete variables (ascites and encephalopathy). Each variable was scored 1-3 with 3 indicating most severe derangement. The determination of Child-Pugh score ranged from 5 to 15. The higher the score, the sicker the participant.

Posted

Median

Inter-Quartile Range

score on a scale

Baseline, Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Number of Participants by Child-Pugh Score Component Category (Ascites Categories)

Number of participants with Child-Pugh component - ascites categories of none, mild, and moderate-severe has been reported. The ascites categories were defined per investigator's discretion.

Posted

Count of Participants

Participants

Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Number of Participants by Child-Pugh Score Component Category (Prothrombin Time Categories)

Number of participants with Child-Pugh component - prothrombin time (measured as INR) in categories of <1.7, 1.7 - 2.3, and >2.3 has been reported.

Posted

Count of Participants

Participants

Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Number of Participants by Child-Pugh Score Component Category (Serum Albumin Categories)

Number of participants with Child-Pugh component - serum albumin levels in categories of >35 gram per liter (g/L), 28-35 g/L, or <28 g/L has been reported.

Posted

Count of Participants

Participants

Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Number of Participants by Child-Pugh Score Component Category (Total Bilirubin Categories)

Number of participants with Child-Pugh component - total bilirubin levels in categories of <34 micromole per liter (µmol/L), 34-50 µmol/L, and >50 µmol/L has been reported.

Posted

Count of Participants

Participants

Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Number of Participants by Child-Pugh Score Component Category (Hepatic Encephalopathy Categories)

Number of participants with Child-Pugh component - Hepatic encephalopathy in categories of Grade 0, Grade 1 or 2, and Grade 3 and 4 has been reported.

Grade 0: normal consciousness, normal personality, normal neurological examination, normal electroencephalogram.

Grade 1: restless, sleep disturbed, irritable/agitated, tremor, impaired handwriting, 5 cycles, per second (cps) waves.

Grade 2: lethargic, time-disoriented, inappropriate, asterixis, ataxia, slow triphasic waves.

Grade 3: somnolent, stuporous, place-disoriented, hyperactive reflexes, rigidity, slower waves.

Grade 4: unrousable coma, no personality/behavior, decerebrate, slow 2-3 cps delta activity.

Posted

Count of Participants

Participants

Day 1, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)

Secondary

Change From Baseline in Total Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

μmol/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Direct Bilirubin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

μmol/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Alkaline Phosphatase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

unit per liter (U/L)

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Alanine Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

U/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Aspartate Aminotransferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

U/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Gamma Glutamyl Transferase at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

U/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Prothrombin INR at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

INR

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Creatinine at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

µmol/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Albumin at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

g/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Platelets at Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

Posted

Median

Inter-Quartile Range

10^9/L

Baseline, Weeks 3, 6, 12, 18, 24, 30, 36, 42, and 48; and Extension Months 3, 6, 9, 12, and 15

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Total Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

Total bile acids (micromole [μM]) = total ursodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM.

Posted

Median

Inter-Quartile Range

μM

Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Total Endogenous Bile Acids Concentration at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

Total endogenous bile acids (μM) = total chenodeoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total deoxycholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total cholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM + total lithocholic acid (unconjugated, glyco-conjugate, tauro-conjugate) in μM.

Posted

Median

Inter-Quartile Range

μM

Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48 weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in 7α-hydroxy-4-cholesten-3-one (C4) at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

Posted

Median

Inter-Quartile Range

ng/mL

Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Secondary

Change From Baseline in Fibroblast Growth Factor-19 (FGF-19) Concentrations at Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

Posted

Median

Inter-Quartile Range

picograms per milliliter (pg/mL)

Baseline, Weeks 6, 12, 18, 24, 30, 36, and 48; and Extension Month 3

ID	Title	Description
OG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).
OG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received OCA matching placebo tablets orally once weekly or twice weekly for the duration of at least 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).	2	12	9	12	10	12
EG001	Obeticholic Acid (OCA)	Participants initiated treatment with OCA 5 mg tablets orally once weekly. At Week 12, if there were no safety concerns, the dose was up-titrated to OCA 5 mg twice weekly. Every 6 weeks thereafter, based on tolerability assessments, further up-titration of dose was considered. At each titration visit, the participants started the higher dose regimen no earlier than 2 days after the prior dose. The maximum dose titration was OCA 10 mg twice weekly at least 3 days apart. The minimum treatment duration was 48-weeks. Participants, who had completed their 48-week treatment, could continue the treatment until all randomized participants had completed their 48-week treatment period and the database for that period was locked (total duration: approximately up to 3 years).	2	10	7	10	10	10

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Oesophageal varices haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0013 affected10 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk
Ascites	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Hepatic failure	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Hepatic function abnormal	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
COVID-19	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Hydrothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Liver transplant	Surgical and medical procedures	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Aortic aneurysm rupture	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Ascites	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected12 at risk EG0016 affected10 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0003 affected12 at risk EG0012 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0012 affected10 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Flatulence	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Frequent bowel movements	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Melaena	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Gastric antral vascular ectasia	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Gastric polyps	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Irritable bowel syndrome	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Portal hypertensive gastropathy	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Toothache	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Varices oesophageal	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0013 affected10 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk
Cytomegalovirus infection reactivation	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Herpes zoster	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Oesophageal candidiasis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Peritonitis bacterial	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Ear infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Fungal infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Influenza	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Skin infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Chest discomfort	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Disease progression	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Oedema peripheral	General disorders	MedDRA 24.0	Systematic Assessment	EG0004 affected12 at risk EG0011 affected10 at risk
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Dizziness	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Balance disorder	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Burning sensation	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk
Hepatic encephalopathy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk
Neuralgia	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Memory impairment	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Sciatica	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0013 affected10 at risk
Skin mass	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Palmar erythema	Skin and subcutaneous tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0013 affected10 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk
Limb mass	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Muscular weakness	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Palpitations	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Portal vein thrombosis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Blood alkaline phosphatase increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Blood bilirubin increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0011 affected10 at risk
Blood urea increased	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Cardiac murmur	Investigations	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0012 affected10 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0012 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Thyroid mass	Endocrine disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Vitreous floaters	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Vision blurred	Eye disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Tooth fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0011 affected10 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0002 affected12 at risk EG0010 affected10 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Breast pain	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Peripheral coldness	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 affected12 at risk EG0011 affected10 at risk
Haematoma	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk
Haemorrhage	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0001 affected12 at risk EG0010 affected10 at risk

ID	Term
D008105	Liver Cirrhosis, Biliary
D005355	Fibrosis

ID	Term
D002780	Cholestasis, Intrahepatic
D002779	Cholestasis
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases
D008107	Liver Diseases
D008103	Liver Cirrhosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms