NCT02039219

Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

A Double-Blind, Placebo-Controlled Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Naga P. Chalasani · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alcoholic Hepatitis

Interventions

Type	Name	Description
DRUG	Placebo	1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
DRUG	10 mg Obeticholic Acid (OCA)	10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.

Timeline

• Start date: 2014-11-03
• Primary completion: 2017-07-30
• Completion: 2018-01-29
• First posted: 2014-01-17
• Last updated: 2020-01-28
• Results posted: 2020-01-28

Locations

4 sites across 1 country: United States