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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001590-41 | EudraCT Number |
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A multi-part study to assess safety, tolerability and efficacy of tropifexor (LJN452) in patients with primary biliary cholangitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LJN452 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Part 1: LJN452 | Drug | LJN452 capsules administered once daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fold Change in Serum Gamma-glutamyl Transferase (GGT) | Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28 | Baseline to Day 28 |
| Blood Pressure | Vital signs - Systolic Blood pressure | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| Pulse Rate | Vital signs | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| Body Temperature | Vital signs | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| ECG - Heart Rate | Electrocardiogram (ECG) | Screening, Baseline, day 1, day 28 |
| ECG Intervals - PR Interval | Electrocardiogram (ECG) | Screening, Baseline, day 1, day 28 |
| Haemoglobin | Hematology panel for safety laboratory assessments. | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma PK Parameter - AUC 0-8h | Tropifexor levels were determined in plasma using a validated LC-MS/MS method. AUC0-t=The area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [mass x time / volume] | Day 1, Day 28 |
| Plasma PK Parameter - Cmax |
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Inclusion Criteria:
Age ≥ 18 years
Diagnosis of PBC as demonstrated by the presence of at least 2 of the following 3 diagnostic criteria:
At least 1 of the following markers of disease severity:
In addition, patients must meet the following biochemical criteria at enrollment:
Taking UDCA for at least 12 months, or for at least 6 months and has reached maximal response to UDCA with a plateau in alkaline phosphatase, with no changes in dose for ≥ 3 months prior to Day 1.
Patients must weigh at least 40 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 40 kg/m2. BMI = Body weight (kg) / [Height (m)]2
Exclusion Criteria:
Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception for 30 days before randomization, during dosing and for 30 days following the end of treatment.
Presence of other concomitant liver diseases.
Significant hepatic impairment as defined by Child-Pugh classification of B or C, history of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score ≥15.
History of conditions that may cause increases in ALP (e.g., Paget's disease).
Use of investigational drugs, or immunosuppressive drugs at the time of enrollment, or within 5 half-lives, or 30 days of randomization, whichever is longer; or longer if required by local regulations. Use of high dose oral steroids to treat co-morbid conditions (e.g., airways disease) will be allowed but must be properly documented as such in concomitant medications.
Currently taking obeticholic acid or have taken obeticholic acid within 30 days of randomization
Previous participation in CLJN452X2201 and received study medication within three months of randomization (or longer if required by local regulations).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Rialto | California | 92377 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36267872 | Derived | Schramm C, Wedemeyer H, Mason A, Hirschfield GM, Levy C, Kowdley KV, Milkiewicz P, Janczewska E, Malova ES, Sanni J, Koo P, Chen J, Choudhury S, Klickstein LB, Badman MK, Jones D. Farnesoid X receptor agonist tropifexor attenuates cholestasis in a randomised trial in patients with primary biliary cholangitis. JHEP Rep. 2022 Jul 21;4(11):100544. doi: 10.1016/j.jhepr.2022.100544. eCollection 2022 Nov. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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This study comprised of an escalating multiple dose design in PBC patients with incomplete biochemical response to, but still taking, ursodeoxycholic acid (UDCA).
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| ID | Title | Description |
|---|---|---|
| FG000 | LJN452 - 0.03 mg qd | Tropifexor 0.03 mg daily for 28 days |
| FG001 | LJN452 - 0.06 mg qd | Tropifexor 0.06 mg daily for 28 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 27, 2017 | Aug 1, 2019 |
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| Part 1: Placebo | Drug | Matching placebo capsules administered once daily for 28 days |
|
| Part 2: LJN452 Dose level 1 | Drug | LJN452 capsules administered once a day for 12 weeks |
|
|
| Part 2: Placebo | Drug | Matching placebo to LJN452 administered once a day for 12 weeks |
|
| Part 2: LJN452 Dose level 2 | Drug | LJN452 |
|
|
Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Cmax=The observed maximum plasma concentration following drug administration [mass /volume] |
| Day 1, Day 28 |
| Plasma PK Parameter - Tmax | Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Tmax = The time to reach the maximum concentration after drug administration [time] | Day 1, Day 28 |
| Changes From Baseline in Total PBC-40 Score | Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. All questions within a domain are summed and all domain totals are summed to obtain a total score. The total score range is between a minimum of 40 and a maximum of 200. Higher scores represent a poorer quality of life. The median difference from baseline in total sum score for each treatment group is presented. | Baseline, Day 28, Day 56, Day 84 |
| Change From Baseline in Itch Subdomain of PBC-40 Score | Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. This dataset focuses on the itch subdomain which consists of 3 questions. These 3 questions within the itch subdomain are summed to obtain a total score for the itch subdomain. The total score range is between a minimum of 3 and a maximum of 15. Higher scores represent a poorer quality of life. The median change from baseline in total itch subdomain score in each treatment group is presented. | Baseline, Day 28, Day 56, Day 84 |
| Change From Baseline in Global Itch Visual Analogue Scale (VAS) | Baseline is defined as the latest available predose value. The Global Itch Visual Analogue Scale, a 100 mm visual analogue scale (VAS), was used to assess the severity of patients itch (ranging from 0 = none at all to 100 = the worst imaginable itch). The score range is between a minimum of 0 and a maximum of 100. The score (distance in mm from left) on the VAS was recorded by the patient marking with a line and used to test for an effect of tropifexor over placebo. The mean change from baseline in itch VAS score in each treatment group is presented. | Day 7, Day 14, Day 21, Day 28, Day 56, and Day 84 |
| Miami |
| Florida |
| 33136 |
| United States |
| Novartis Investigative Site | Atlanta | Georgia | 30308 | United States |
| Novartis Investigative Site | Marietta | Georgia | 30060 | United States |
| Novartis Investigative Site | Chicago | Illinois | 60612 | United States |
| Novartis Investigative Site | Manhasset | New York | 11030 | United States |
| Novartis Investigative Site | Dallas | Texas | 75390 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78215 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| Novartis Investigative Site | Calgary | Alberta | T2N 4N1 | Canada |
| Novartis Investigative Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Novartis Investigative Site | Hamburg | 20246 | Germany |
| Novartis Investigative Site | Hanover | 30625 | Germany |
| Novartis Investigative Site | Heidelberg | 69120 | Germany |
| Novartis Investigative Site | München | 81377 | Germany |
| Novartis Investigative Site | Würzburg | 97080 | Germany |
| Novartis Investigative Site | Lodz | 91-347 | Poland |
| Novartis Investigative Site | Mysłowice | 41-400 | Poland |
| Novartis Investigative Site | Warsaw | 02-097 | Poland |
| Novartis Investigative Site | Wroclaw | 50-449 | Poland |
| Novartis Investigative Site | Moscow | 117198 | Russia |
| Novartis Investigative Site | Saint Petersburg | 194044 | Russia |
| Novartis Investigative Site | Samara | 443011 | Russia |
| Novartis Investigative Site | Birmingham | West Midlands | B15 2TH | United Kingdom |
| Novartis Investigative Site | Cambridge | CB2 2QQ | United Kingdom |
| Novartis Investigative Site | Hull | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | London | NW3 2PF | United Kingdom |
| Novartis Investigative Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| FG002 | LJN452 - 0.09 mg qd | Tropifexor 0.09 mg daily for 28 days |
| FG003 | LJN452 - 0.15 mg qd | Tropifexor 0.15 mg daily for 28 days |
| FG004 | Placebo qd | Tropifexor placebo daily for 28 days |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set included all subjects who received any study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | LJN452 - 0.03 mg qd | Tropifexor 0.03 mg daily for 28 days |
| BG001 | LJN452 - 0.06 mg qd | Tropifexor 0.06 mg daily for 28 days |
| BG002 | LJN452 - 0.09 mg qd | Tropifexor 0.09 mg daily for 28 days |
| BG003 | LJN452 - 0.15 mg qd | Tropifexor 0.15 mg daily for 28 days |
| BG004 | Placebo qd | Tropifexor placebo daily for 28 days |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fold Change in Serum Gamma-glutamyl Transferase (GGT) | Fold change in serum gamma-glutamyl transferase (GGT) from baseline to Day 28 | The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | 90% Confidence Interval | fold-change | Baseline to Day 28 |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Blood Pressure | Vital signs - Systolic Blood pressure | Safety Analysis Set | Posted | Mean | Standard Deviation | mm Hg | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Pulse Rate | Vital signs | Safety Analysis Set | Posted | Mean | Standard Deviation | bpm | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Body Temperature | Vital signs | Safety Analysis Set | Posted | Mean | Standard Deviation | Celsius | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | ECG - Heart Rate | Electrocardiogram (ECG) | Safety Analysis Set | Posted | Mean | Standard Deviation | bpm | Screening, Baseline, day 1, day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | ECG Intervals - PR Interval | Electrocardiogram (ECG) | Safety Analysis Set | Posted | Mean | Standard Deviation | msec | Screening, Baseline, day 1, day 28 |
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| Primary | Haemoglobin | Hematology panel for safety laboratory assessments. | Safety Analysis Set | Posted | Mean | Standard Deviation | g/L | Screening, Baseline, day 1, day 7, day 14, day 21, day 28, day 56, day 84 |
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| Secondary | Plasma PK Parameter - AUC 0-8h | Tropifexor levels were determined in plasma using a validated LC-MS/MS method. AUC0-t=The area under the plasma concentration-time curve from time zero to time 't' where t is a defined time point after administration [mass x time / volume] | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | hr*ng/mL | Day 1, Day 28 |
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| Secondary | Plasma PK Parameter - Cmax | Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Cmax=The observed maximum plasma concentration following drug administration [mass /volume] | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Mean | Standard Deviation | ng/mL | Day 1, Day 28 |
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| Secondary | Plasma PK Parameter - Tmax | Tropifexor levels were determined in plasma using a validated LC-MS/MS method. Tmax = The time to reach the maximum concentration after drug administration [time] | The PK analysis set included all subjects with available PK data and no protocol deviations with relevant impact on PK data. | Posted | Median | Inter-Quartile Range | hr | Day 1, Day 28 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Changes From Baseline in Total PBC-40 Score | Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. All questions within a domain are summed and all domain totals are summed to obtain a total score. The total score range is between a minimum of 40 and a maximum of 200. Higher scores represent a poorer quality of life. The median difference from baseline in total sum score for each treatment group is presented. | The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data. | Posted | Median | Full Range | units on a scale | Baseline, Day 28, Day 56, Day 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Itch Subdomain of PBC-40 Score | Baseline is defined as the latest available predose value. The PBC-40 is a paper-based, patient-derived, disease-specific health-related quality of life (HRQOL) patient reported outcome (PRO) measure which was developed and validated for use in PBC patients (Jacoby et al 2005). It consists of 40 questions arranged in 6 domains with between 3 and 11 questions in each domain. Each question is scored from 1 to 5 in increasing order of severity. This dataset focuses on the itch subdomain which consists of 3 questions. These 3 questions within the itch subdomain are summed to obtain a total score for the itch subdomain. The total score range is between a minimum of 3 and a maximum of 15. Higher scores represent a poorer quality of life. The median change from baseline in total itch subdomain score in each treatment group is presented. | The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data. | Posted | Median | Full Range | UNITS ON A SCALE | Baseline, Day 28, Day 56, Day 84 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Global Itch Visual Analogue Scale (VAS) | Baseline is defined as the latest available predose value. The Global Itch Visual Analogue Scale, a 100 mm visual analogue scale (VAS), was used to assess the severity of patients itch (ranging from 0 = none at all to 100 = the worst imaginable itch). The score range is between a minimum of 0 and a maximum of 100. The score (distance in mm from left) on the VAS was recorded by the patient marking with a line and used to test for an effect of tropifexor over placebo. The mean change from baseline in itch VAS score in each treatment group is presented. | The PD analysis set included all subjects with any available PD data and no protocol deviations with relevant impact on PD data. | Posted | Mean | 90% Confidence Interval | mm | Day 7, Day 14, Day 21, Day 28, Day 56, and Day 84 |
|
Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 56 days post last dose.
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LJN452 - 0.03 mg qd | Tropifexor 0.03 mg daily for 28 days | 0 | 11 | 0 | 11 | 9 | 11 |
| EG001 | LJN452 - 0.06 mg qd | Tropifexor 0.06 mg daily for 28 days | 0 | 9 | 0 | 9 | 8 | 9 |
| EG002 | LJN452 - 0.09 mg qd | Tropifexor 0.09 mg daily for 28 days | 0 | 12 | 0 | 12 | 11 | 12 |
| EG003 | LJN452 - 0.15 mg qd | Tropifexor 0.15 mg daily for 28 days | 0 | 8 | 0 | 8 | 8 | 8 |
| EG004 | Placebo qd | Tropifexor placebo daily for 28 days | 0 | 21 | 0 | 21 | 16 | 21 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Trifascicular block | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Varices oesophageal | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Overgrowth bacterial | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Low density lipoprotein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Optic neuritis | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vulvovaginal discomfort | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 4, 2018 | Sep 16, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000630573 | tropifexor |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Other |
|
| adjusted fold change from baseline |
| 0.47 |
| 2-Sided |
| 90 |
| 0.37 |
| 0.60 |
| Other |
| ANCOVA | <.001 | adjusted fold change from baseline | 0.32 | 2-Sided | 90 | 0.26 | 0.40 | Other |
| ANCOVA | <.001 | adjusted fold change from baseline | 0.36 | 2-Sided | 90 | 0.27 | 0.47 | Other |
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| Participants |
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| Participants |
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| Participants |
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| OG003 | LJN452 - 0.15 mg qd | Tropifexor 0.15 mg daily for 28 days. |
| OG004 | Placebo qd | Tropifexor placebo daily for 28 days |
|
|
|
Tropifexor 0.09 mg daily for 28 days. |
| OG003 | LJN452 - 0.15 mg qd | Tropifexor 0.15 mg daily for 28 days. |
| OG004 | Placebo qd | Tropifexor placebo daily for 28 days |
|
|
|
| LJN452 - 0.15 mg qd |
Tropifexor 0.15 mg daily for 28 days |
| OG004 | Placebo qd | Tropifexor placebo daily for 28 days |
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