Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
Summary
The main purpose of this study is to test the effectiveness of Obeticholic Acid when used in patients with moderately severe alcoholic hepatitis. The researchers suspect that individuals with alcoholic hepatitis have certain abnormalities in how their body handles bile acids (a product made by the liver on a daily basis) produced by the liver. Obeticholic acid has been shown to affect bile acid abnormalities and thus it is possible that obeticholic acid may improve liver condition in individuals with alcoholic hepatitis.
Timeline
- Start
- 2014-11-03
- Primary completion
- 2017-07-30
- Completion
- 2018-01-29
Outcome
Missed primary endpoint
Stopped (Enrollment): “Post-marketing reports of hepatotoxicity associated with obeticholic acid emerged in June 2017, investigators temporarily halted patient recruitment June 2017.”
registry analysis (superiority test); 10 mg Obeticholic Acid (OCA); p = 0.1758; Mean Difference (Net) 1.5; t-test, 2 sided NCT02039219 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obeticholic Acid | Small molecule | 10 mg | Oral |