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

NCT02039219 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-01-28

Study results available
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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

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.

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Intercept Pharmaceuticals

    collaborator INDUSTRY

  • Naga P. Chalasani

    lead OTHER

Principal Investigators

  • Naga Chalasani, MD · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-03
Primary Completion
2017-07-30
Completion
2018-01-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02039219 on ClinicalTrials.gov