drugset / Trial / NCT03439254
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
Timeline
- Start
- 2017-08-30
- Primary completion
- 2022-09-08
- Completion
- 2022-09-08
Outcome
Missed primary endpoint
registry analysis (other test); DB: Placebo vs DB: OCA 10 Milligrams (mg); p = 0.6172; Response ratio(Mantel-Haenszel estimate) 1.13 (95% CI 0.71 to 1.79) NCT03439254 ↗
registry analysis (other test); DB: Placebo vs DB: OCA 10 mg Titrated to OCA 25 mg; p = 0.4184; Response ratio(Mantel-Haenszel estimate) 1.20 (95% CI 0.77 to 1.89) NCT03439254 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obeticholic Acid | Small molecule | 10 mg | Oral |
| Subject | Obeticholic Acid | Small molecule | 25 mg | Oral |