6 completed, 6 terminated. 12 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 6, Terminated 6 |
| Phase 3 | 1 | Terminated 1 |
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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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis Obeticholic Acid - Primary Biliary Cirrhosis | Phase 2 | Completed | Intercept Pharmaceuticals | 27 | 2013-12-03 | 2022-08-24 |
| Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC) Placebo, Obeticholic Acid (OCA) - Liver Cirrhosis, Biliary | Phase 2 | Completed | Intercept Pharmaceuticals | 60 | 2008-01-17 | 2021-06-22 |
| Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC) INT-747, Ursodeoxycholic Acid (URSO), Placebo - Liver Cirrhosis, Biliary | Phase 2 | Terminated | Intercept Pharmaceuticals | 165 | 2007-10-01 | 2024-02-06 |
| Study of INT-747 in Patients With Diabetes and Presumed NAFLD INT-747, Placebo - Diabetes Mellitus, Type II, Fatty Liver | Phase 2 | Completed | Intercept Pharmaceuticals | 64 | 2007-07-01 | 2012-04-20 |
Liver Cirrhosis, Biliary (5) · Biliary Atresia (2) · Fibrosis (2) · Hepatitis, Alcoholic (2) · Non-alcoholic Fatty Liver Disease (2) · Cholangitis, Sclerosing (1) · Diabetes Mellitus (1) · Diabetes Mellitus, Type 2 (1) · Fatty Liver (1) · Hepatitis (1) · Metabolic Diseases (1)
obeticholic acid (10) · Bezafibrate (2) · Atorvastatin (1) · Ursodeoxycholic Acid (1)
United States (9) · France (5) · United Kingdom (5) · Canada (4) · Germany (4) · Spain (4) · Israel (3) · Italy (3) · Netherlands (3) · Australia (2) · Austria (2) · Belgium (2) · Poland (2) · Argentina (1) · China (1)
George Harb, MD (2) · Lynda Szczech, MD (2) · Christian Weyer, MD (1) · David A Shapiro, M.D. (1) · David A Shapiro, MD (1) · David Shapiro, MD (1) · Lynda Szczech (1) · Lynda Szczech, M.D. (1) · Naga Chalasani, MD (1)
PMID 23727264, PMID 25500425, PMID 31402538, PMID 32165251
2014 (1), U01AA021788 (1), U01AA021840 (1), U01AA021883 (1), U01AA021891 (1)