| Primary | Time to the First Occurrence of Composite Endpoint | To assess the effect of OCA, compared to placebo in conjunction with the established local standard of care, on clinical outcomes in participants with PBC as measured by time to the first occurrence of any of the following adjudicated events, derived as a composite event endpoint of death, liver transplant, model of end-stage liver disease (MELD) ≥15, uncontrolled ascites, or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), or spontaneous bacterial peritonitis. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% confidence intervals (CIs) for the clinical events distribution percentiles (25th and 50th) are provided. | The Intent-to-Treat (ITT) population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | days | | Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| | | Title | Denominators | Categories |
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| 25th Percentile | | | Title | Measurements |
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| - OG0001092(670 to 1464)
- OG001970(688 to 1342)
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| | 50th Percentile | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Log Rank | | 0.954 | Log rank p-value and hazard ratio are based on stratified analyses, with the randomization stratification factors entered in the interactive web response system (IWRS) as strata | Hazard Ratio, log | 1.01 | | | 2-Sided | 95 | 0.68 | 1.51 | | | | | Superiority | | |
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| Primary | Time to the First Occurrence of Primary Clinical Event (Expanded Endpoint) | Primary clinical outcome event is the first occurrence of the following events: death, liver transplant, MELD score >=15 (MELD-Na score >=12 baseline), MELD-Na score >=15 (MELD-Na score <12 baseline), hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis), or bacterial empyema, uncontrolled or refractory ascites (requiring large volume paracentesis), portal hypertension syndromes, progression to decompensated liver disease, and progression to clinical evidence of portal hypertension without decompensation (for participants without decompensation or clinical evidence of portal hypertension at baseline). 71 endpoint events were observed in the OCA arm, and 80 were observed in the Placebo arm. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | days | | Time to first occurrence from date of randomization until the time to accrue approximately 127 primary endpoint events (up to 7 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. |
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| Secondary | Time To First Occurrence Of Severe Decompensating Events of Expanded Composite Endpoint | The first occurrence of the key secondary clinical event refers to the first occurrence of the following events: death, liver transplant, MELD-Na score >=15 if MELD-Na< 12 at baseline, MELD score >=15 if MELD-Na >=12 at baseline, uncontrolled or refractory ascites, portal hypertension syndromes (hepatorenal syndrome, portopulmonary syndrome, hepatopulmonary syndrome) or hospitalization for new onset or recurrence of variceal bleed, hepatic encephalopathy, spontaneous bacterial peritonitis, or bacterial empyema. The clinical events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | days | | Time to first occurrence from date of randomization until the date of first documented progression or date of death from any cause, whichever came first (up to 7 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. |
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| Secondary | Time To Liver Transplant Or Death (All-cause) | The effect of OCA compared to placebo on time to liver transplant or death (all-cause) was assessed. The events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the clinical events distribution percentiles (25th and 50th) are provided. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | days | | Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 7 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time to First Occurrence of Fatal Event (All-Cause) | The results represent the ratio of OCA to placebo. The fatal events distribution was estimated using the Kaplan-Meier methodology. Point estimates and 95% CIs for the fatal events distribution percentiles (25th and 50th) are provided | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | days | | Time to first occurrence from date of randomization until the date of death from any cause (up to 7 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time to First Occurrence of Liver Transplant | The effect of OCA compared to placebo on time to occurrence of a liver transplant was assessed. The results represented the ratio of OCA to placebo. A hazard ratio <1 indicated an advantage for OCA. The event of interest was summarized through Cumulative Incidence Function (CIF) estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of first documented liver transplant or date of death from any cause (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time to First Occurrence of Hospitalization Due to Hepatic Events | Hospitalization events include new onset or recurrent variceal bleed, hepatic encephalopathy (as defined by a West Haven score of >=2), spontaneous bacterial peritonitis (confirmed by diagnostic paracentesis OR presence of >250/mm^3 polymorph leucocytes [PMNs] in the ascitic fluid), bacterial empyema is confirmed by diagnostic thoracentesis OR presence of >250/mm^3 PMNs in the pleural fluid. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of hospitalization, liver transplant or death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo |
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| Secondary | Time to First Occurrence of Uncontrolled or Refractory Ascites | Uncontrolled or refractory ascites are defined as diuretic-resistant ascites requiring large-volume paracentesis. The effect of OCA compared to placebo on time to the first occurrence of uncontrolled or refractory ascites was assessed. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of first documented uncontrolled or refractory ascites, liver transplant or date of death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time to First Occurrence of MELD Score ≥15 | The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and International Normalized Ratio (INR), as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of first documented MELD Score ≥15, liver transplant or date of death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. |
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| Secondary | Time To Development Of Varix/Varices | The effect of OCA compared to placebo on time to development of varix/varices was assessed. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of first documented development of varix/varices, liver transplant or death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time To Liver-Related Death | The effect of OCA compared to placebo on time to liver-related death was assessed. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of first liver-related or non-liver- related death, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time To Liver-Related Death Or Liver Transplant | The effect of OCA compared to placebo on time to liver-related death or liver transplant was assessed. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of liver transplant, liver-related death or non-liver-related death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Time To Liver-Related Death, Liver Transplant, Or MELD Score ≥15 | The effect of OCA compared to placebo on time to liver-related death, liver transplant, or MELD Score ≥15 was assessed. The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of liver transplant, liver-related death, non-liver-related death from any cause or MELD Score ≥15, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. |
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| Secondary | Progression To Cirrhosis (for Noncirrhotic Subjects at Baseline) | When a participant is identified as noncirrhotic at the Baseline and exhibited any signs or symptoms associated with progression to cirrhosis, the participant was assessed by Fibroscan® TE where available. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of cirrhosis, liver transplant or death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Time To Occurrence Of Hepatocellular Carcinoma (HCC) | The effect of OCA compared to placebo on time to occurrence of HCC was assessed. The event of interest was summarized through CIF estimate at 5 years. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Number | 95% Confidence Interval | proportion of participants | | Time to first occurrence from date of randomization until the date of HCC diagnosis, liver transplant or death from any cause, whichever came first (up to 5 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 24 Of Total Bilirubin | Liver biochemistry, which includes total bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using mixed model repeated measures (MMRM), including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 24 Of Direct Bilirubin | Liver biochemistry, which includes direct bilirubin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | mg/dL | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 24 Of Aspartate Aminotransferase (AST) | Liver biochemistry, which includes AST, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 24 Of Alanine Aminotransferase (ALT) | Liver biochemistry, which includes ALT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 24 Of Alkaline Phosphatase (ALP) | Liver biochemistry, which includes ALP, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 24 Of Gamma-glutamyl Transferase (GGT) | Liver biochemistry, which includes GGT, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | U/L | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 24 Of Albumin | Liver biochemistry, which includes albumin, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | g/L | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
|
| Secondary | Change From Baseline To Month 24 Of INR | The coagulation test, which includes INR, was assessed to evaluate biochemical triggers that would prompt an immediate reevaluation of participants for potential hepatic injury or hepatic decompensation. INR is the ratio of tested prothrombin time to normal prothrombin time, to a power designated the international sensitivity index (ISI). INR normal range is 0.8 to 1.2 (female and male). Analysis was performed using MMRM, including treatment group, time, treatment group by time interaction, and randomization stratification factors as entered in the IWRS as fixed effects and baseline values as a covariate. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Least Squares Mean | Standard Error | ratio | | Baseline up to Month 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | |
|
| Secondary | Change From Baseline To Month 72 Of MELD Score | The MELD score is useful in assessing participants with significant decompensation. The MELD score is now used by the United Network for Organ Sharing in the United States and Eurotransplants to manage organ allocation for liver transplantation. The MELD score is derived from the participant's serum total bilirubin, serum creatinine, and INR, as appropriate, to predict survival. The MELD score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
|
| Secondary | Change From Baseline To Month 72 Of MELD-Na Score | The MELD-Na score is another useful predictor in assessing participants with significant decompensation. The MELD-Na took into account the effect of serum sodium as a reflection of renal function and hypothetically may improve the accuracy of the model score. The MELD-Na score is derived from the participant's serum total bilirubin, serum creatinine, INR, and serum sodium, as appropriate, to predict survival. The MELD-Na score ranges from 6 to 40. The higher the score, the more likely a participant will receive a liver from a deceased donor when an organ becomes available. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | |
|
| Secondary | Change From Baseline To Month 72 Of CPS | Child-Pugh Score (Pugh 1973, Lucey 1997) was calculated and reported within the electronic data capture (EDC) system based on data entered into the CRF by adding the scores from the 5 factors and could have ranged from 5 to15. A total score of 5 to 6 was considered Grade A (mild, well-compensated disease); 7 to 9 was Grade B (moderate, significant functional compromise); and 10 and above was Grade C (severe, decompensated disease). | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
|
| Secondary | Change From Baseline To Month 72 Of Mayo Risk Score (MRS) | Mayo Risk Score (MRS) was calculated and reported within the EDC system. Calculation of MRS included Investigator assessment of peripheral edema and the use of diuretic therapy, which was assessed during the adverse event and concomitant medicine review at the scheduled visits and entered into the CRF, as well as total bilirubin, albumin, and prothrombin time results obtained from the central laboratory data. There is no maximum and minimum range of score but an increase in the MRS represents an increase in the risk of death. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
|
| Secondary | Change From Baseline To Month 72 Of Immunoglobulin-M (IgM) | Markers of inflammation, which include IgM, were assessed. | The ITT population included all randomized participants who received any dosage of OCA or placebo | Posted | | Median | Inter-Quartile Range | g/L | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 72 Of C-reactive Protein (CRP) | Markers of inflammation, which include CRP, were assessed. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | mg/L | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 72 Of Tumor Necrosis Factor-α (TNF-α) | Markers of inflammation, which include TNF-α, were assessed. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 72 Of Fibroblast Growth Factor-19 (FGF-19) | Markers of hepatic fibrosis, which include FGF-19, were assessed. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | pg/mL | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 72 Of Cytokeratin-18 (CK-18) | Markers of inflammation, which include CK-18, were assessed. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | U/L | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 72 Of 7α-hydroxy-4-cholesten-3-one (C4) | Markers of hepatic fibrosis, which include C4, were assessed. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | ng/mL | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Change From Baseline To Month 72 Of Enhanced Liver Fibrosis (ELF) | Liver fibrosis was assessed using ELF test. The ELF test assessed: hyaluronic acid, procollagen3 N-terminal peptide, and a tissue inhibitor of metalloproteinase 1. The ELF test is a composite score: < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline suggests decreased fibrosis. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | score on a scale | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
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| Secondary | Change From Baseline To Month 72 Of Liver Stiffness - Transient Elastography | Hepatic stiffness was measured using non-invasive transient Elastography with Fibroscan® TE device. | The ITT population included all randomized participants who received any dosage of OCA or placebo. | Posted | | Median | Inter-Quartile Range | kPa | | Baseline up to Month 72 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. | | OG001 | Placebo | Participants received one tablet daily (or a lower frequency depending on CP score) for the remainder of the study. |
| |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An adverse event (AE) was defined as any unfavorable and unintended sign (for example, including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product or procedure, whether or not considered related to the medicinal product or procedure, which occurred during the course of the clinical study. TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section. | The safety population consisted of all participants who received any amount of OCA or placebo. Treatment assignment based on the treatment received before any initiation of commercial OCA. | Posted | | Number | | participants | | Baseline up to the last IP dose plus 30 days and prior to commercial OCA initiation date (up to 7 years) | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants received OCA 5 mg for a minimum of 3 months and titrating up to 10 mg for the remainder of the study (based on tolerability and CP Score). Non-cirrhotic and classified as CP Class A: 5 mg tablet of OCA once daily, titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of participants). Cirrhotic and classified as CP Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, titrating up to a maximum dose and frequency of 10 mg twice weekly based on tolerability and biochemical response for the duration of the study. |
|
| Secondary | Pharmacokinetic (PK) Population: Fasting Trough Concentrations Of OCA By Dose Regimen | The fasting trough PK concentrations of OCA of different dose regimens taken throughout the study are reported. | The PK Population included all OCA participants who had at least 1 confirmed fasted analyzable sample. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 3, 6, 9, 12, 24, 36, 48, and 60 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Serial Concentration of OCA By Dose Regimen | In Month 9, blood samples were collected at predose, 0.5 h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h and PK serial concentrations at different dose regimen are reported. | The PK Population included all OCA participants who had at least 1 confirmed fasted analyzable sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Area Under The Concentration-Time Curve (AUC) From 0 to 6 Hours Post-dose (AUC0-6h) Of Participants Who Received 5 mg QD OCA and With CP Score=Non-Cirrhotic (NC) | In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC From 0 to 24 Hours Post-dose (AUC0-24h) Of Participants Who Received 5 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose, 0.5h, 0.75 h, 1 h, 1.5 h, 2 h, 2.5 h, 3 h, 4h, 5 h, and 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Maximum Observed Concentration (Cmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Time to Cmax (Tmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Metabolite to Parent Ratio of AUC0-6h (MRAUC) Of Participants Who Received 5mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Metabolite to Parent Ratio of Cmax (MRCmax) Of Participants Who Received 5mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 5mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 5mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Concentration at 24 Hours Post-dose (Ctrough) Of Participants Who Received 5mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 5mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 5mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 5mg QD OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 5mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 5mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 5mg QOD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=NC | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QOD OCA with CP Score=NC. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With CPS Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With CPS Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With CP Score=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with CP Score=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With CP Score=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with CP Score=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 5 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 5 mg QOD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 5 mg QOD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=A | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=A. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 10 mg QD OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg QD OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-6h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: AUC0-24h Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | h*ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Cmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Tmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Median | Full Range | hours | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Ctrough Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRAUC Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: MRCmax Of Participants Who Received 10 mg Q2W OCA and With MELD Category=B | In Month 9, blood samples were collected at predose to 6 h for PK analysis in participants who received 10 mg Q2W OCA with MELD Category=B. | Participants in the PK population that had the appropriate CP Score, had received the assigned dosage according to the dosage regimen and had an analyzable sample at month 9. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Month 9 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QD OCA | The trough concentration of OCA in the cirrhotic participants who received 5 mg QD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 3, 6, 12, 24, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QD OCA | The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 3, 6, 9, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QOD OCA | The trough concentration of OCA in the cirrhotic participants who received 5 mg QOD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 6, 12, and 24 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QOD OCA | The trough concentration of OCA in the non-cirrhotic participants who received 5 mg QOD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 3, 6, and 12 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg QW OCA | The trough concentration of OCA in the cirrhotic participants who received 5 mg QW OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 6 and 12 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg QW OCA | In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 5 QW QOD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 5 mg Q2W OCA | The trough concentration of OCA in the cirrhotic participants who received 5 mg Q2W OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 6, 24, 36 and 48 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 5 mg Q2W OCA | The trough concentration of OCA in the non-cirrhotic participants who received 5 Q2W QOD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 3, 6, 12, 24, 36, and 48 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QD OCA | The trough concentration of OCA in the cirrhotic participants who received 10 mg QD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 6, 9, 12, 24, 36, and 60 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QD OCA | The trough concentration of OCA in the non-cirrhotic participants who received 10 QD QOD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Months 6, 9, 12, 24, and 36 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg QOD OCA | | No participant was tested for this outcome measure. | Posted | | | | | | Months 3, 6, 9, 12, 24, 36, 48, and 60 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| | | |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg QOD OCA | In Month 12, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg QOD OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 12 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Cirrhotic Participants Who Received 10 mg Q2W OCA | In Month 6, the trough concentration of OCA in the cirrhotic participants who received 10 mg Q2W OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |
| Secondary | PK Population: Trough Concentrations Of Non-Cirrhotic Participants Who Received 10 mg Q2W OCA | In Month 6, the trough concentration of OCA in the non-cirrhotic participants who received 10 mg Q2W OCA was reported. | Participants in the PK population that had data available for cirrhosis status, mean trough concentrations by presence or absence of cirrhosis and dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Month 6 | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | Participants who had at least 1 confirmed fasted analyzable OCA sample. Participants fasted for approximately 8 hours prior to the visit and had no major protocol deviations that potentially affected exposure levels. |
| |