3 terminated, 2 completed. 5 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 5 | Terminated 3, Completed 2 |
| Phase 2 | 1 | Terminated 1 |
Follow Intercept Pharmaceuticals: new trials by email
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 |
| 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 |
| 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 |
| Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis Obeticholic Acid (OCA), Placebo - Primary Biliary Cirrhosis | Phase 3 | Completed | Intercept Pharmaceuticals | 217 | 2012-01-01 | 2021-05-06 |
Liver Cirrhosis, Biliary (2) · Non-alcoholic Fatty Liver Disease (2) · Biliary Atresia (1) · Fibrosis (1)
obeticholic acid (3)
Australia (5) · Canada (5) · France (4) · Germany (4) · Spain (4) · United Kingdom (4) · United States (4) · Belgium (3) · Hungary (3) · Israel (3) · Italy (3) · New Zealand (3) · Poland (3) · Austria (2) · Netherlands (2)
Christian Weyer, MD (1) · Lynda Szczech, MD (1) · Lynda Szczech, PhD (1) · Sangeeta Sawhney, MD (1)
PMID 25543678, PMID 27532829, PMID 30922873, PMID 31260793, PMID 31606455, PMID 31813633, PMID 33319187, PMID 34274514, PMID 34793868, PMID 38126958, PMID 42449190