14 completed, 11 terminated, 1 active not recruiting, 1 unknown. 12 Phase 2, 5 Phase 3, 3 Not applicable, 3 Phase 1, 2 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Terminated 6 |
| Phase 3 | 5 | Terminated 3, Completed 2 |
| Not applicable | 3 | Completed 1, Terminated 1, Unknown 1 |
| Phase 1 | 3 | Completed 3 |
| Phase 4 | 2 | Terminated 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study to Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy OCA, Matching Placebo - Biliary Atresia | Phase 2 / Phase 3 | Terminated | Intercept Pharmaceuticals | 28 | 2024-09-02 | 2026-07-07 |
| To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate FDC tablet (OCA 5 mg + BZF 400 mg SR) - Primary Biliary Cholangitis | Phase 3 | Terminated | Intercept Pharmaceuticals | 62 | 2024-07-01 | 2026-06-08 |
| FXR Effect on Severe Alcohol-Associated Hepatitis (FRESH) Study INT-787, Placebo - Alcohol Associated Hepatitis | Phase 2 | Terminated | Intercept Pharmaceuticals | 67 | 2022-12-15 | 2026-05-05 |
| The Effect of Obeticholic Acid in Healthy Volunteers Ocaliva, Placebo - Healthy | Not applicable | Unknown | Universitaire Ziekenhuizen KU Leuven | 12 | 2022-08-22 | 2023-02-23 |
| A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients Obeticholic Acid 5 MG, Obeticholic Acid 10 MG, Standard of Care: UDCA - Primary Biliary Cholangitis | Withdrawn | Intercept Pharmaceuticals | 2022-03-28 | 2023-10-10 | ||
| Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg - Primary Biliary Cholangitis | Phase 2 | Completed | Intercept Pharmaceuticals | 72 | 2022-03-21 | 2026-07-16 |
| Study of OCA in Combination With BZF Evaluating Efficacy, Safety, and Tolerability in Participants With PBC Obeticholic acid, Bezafibrate 200 MG, OCA Placebo - Primary Biliary Cholangitis | Phase 2 | Terminated | Intercept Pharmaceuticals | 75 | 2019-10-02 | 2026-07-16 |
| LITMUS Imaging Study NAFLD, NASH | Active not recruiting | University of Oxford | 450 | 2019-09-04 | 2025-04-16 | |
| EXerCise Intervention in cholesTatic LivEr Disease: The EXCITED Study Home-based exercise program - Primary Biliary Cholangitis | Not applicable | Terminated | University of Birmingham | 31 | 2019-04-07 | 2020-07-08 |
| Study of Obeticholic Acid (OCA) Evaluating Pharmacokinetics and Safety in Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment Obeticholic Acid (OCA), Placebo - Liver Cirrhosis, Biliary | Phase 4 | Terminated | Intercept Pharmaceuticals | 22 | 2018-06-22 | 2022-09-06 |
| Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg), Placebo - Compensated Cirrhosis, Nonalcoholic Steatohepatitis | Phase 3 | Completed | Intercept Pharmaceuticals | 919 | 2017-08-30 | 2023-10-23 |
| Effect of Heavy Alcohol Consumption on Farnesoid X Receptor (FXR) Signaling Placebo, 10 mg Obeticholic Acid (OCA) - Alcohol Consumption | Not applicable | Completed | Suthat Liangpunsakul | 30 | 2016-04-01 | 2023-04-25 |
| Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL) Obeticholic Acid, Atorvastatin, Placebo - Nonalcoholic Steatohepatitis | Phase 2 | Completed | Intercept Pharmaceuticals | 84 | 2015-12-04 | 2018-06-04 |
| The Health Burden of Primary Biliary Cirrhosis (PBC) in Switzerland Primary Biliary Cirrhosis | Completed | Fondazione Epatocentro Ticino | 501 | 2015-12-01 | 2025-08-19 | |
| Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment Obeticholic Acid, Placebo - Non Alcoholic Steatohepatitis (NASH) | Phase 3 | Terminated | Intercept Pharmaceuticals | 2477 | 2015-09-22 | 2024-10-01 |
| Obeticholic Acid in Pediatric Subjects With Biliary Atresia OCA 0.1mg, OCA 1.5mg, OCA 5mg - Biliary Atresia | Phase 2 | Terminated | Intercept Pharmaceuticals | 7 | 2015-07-01 | 2023-03-28 |
| Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients Primary Biliary Cholangitis | Completed | Intercept Pharmaceuticals | 4577 | 2015-06-01 | 2025-01-24 | |
| Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC) Obeticholic Acid (OCA), Placebo - Primary Sclerosing Cholangitis (PSC) | Phase 2 | Completed | Intercept Pharmaceuticals | 77 | 2015-02-09 | 2021-07-08 |
| Phase 4 Study of Obeticholic Acid Evaluating Clinical Outcomes in Patients With Primary Biliary Cholangitis Obeticholic Acid (OCA), Placebo - Liver Cirrhosis, Biliary | Phase 4 | Terminated | Intercept Pharmaceuticals | 334 | 2014-12-26 | 2023-03-09 |
| Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) Placebo, 10 mg Obeticholic Acid (OCA) - Alcoholic Hepatitis | Phase 2 | Terminated | Naga P. Chalasani | 19 | 2014-11-03 | 2020-01-28 |
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Liver Cirrhosis, Biliary (13) · Fibrosis (5) · Non-alcoholic Fatty Liver Disease (5) · Biliary Atresia (2) · Fatty Liver (2) · Hepatitis, Alcoholic (2) · Alcohol Drinking (1) · Cholangitis, Sclerosing (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Disease (1) · Fatigue (1) · Hepatitis (1) · Liver Cirrhosis (1) · Metabolic Diseases (1)
obeticholic acid (21) · Bezafibrate (2) · Atorvastatin (1) · Starch (1) · Ursodeoxycholic Acid (1)
United States (22) · United Kingdom (12) · France (11) · Germany (11) · Spain (11) · Canada (10) · Italy (9) · Australia (8) · Belgium (8) · Hungary (6) · Israel (6) · Netherlands (6) · Poland (6) · Austria (5) · Argentina (4)
Lynda Szczech, MD (4) · David Shapiro, MD (3) · Christian Weyer, MD (2) · George Harb, MD (2) · David A Shapiro, M.D. (1) · David A Shapiro, MD (1) · David Shaprio, M.D. (1) · Erik Ness, MD (1) · Lynda Szczech (1) · Lynda Szczech, M.D. (1) · Lynda Szczech, PhD (1) · Michael Pavlides, MBBS, DPhil (1) · Naga Chalasani, MD (1) · Sangeeta Sawhney, MD (1) · Steven Shiff, M.D. (1)
PMID 27743502, PMID 23727264, PMID 25500425, PMID 25543678, PMID 27532829, PMID 29181702, PMID 30144429, PMID 30922873, PMID 31260793, PMID 31402538, PMID 31606455, PMID 31813633, PMID 32165251, PMID 33319187, PMID 33707216, PMID 34274514, PMID 34793868, PMID 38126958, PMID 39140490, PMID 39630028, PMID 39640219, PMID 42449190
2014 (1), U01AA021788 (1), U01AA021840 (1), U01AA021883 (1), U01AA021891 (1)