drugset / Trial / NCT02039219
Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)
Phase 2
Terminated
19 enrolled
Naga P. Chalasani
Intercept Pharmaceuticals · collabNational Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obeticholic Acid | Small molecule | 10 mg | Oral |