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Trial of Obeticholic Acid in Patients With Moderately Severe Alcoholic Hepatitis (AH) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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)

NCT02039219•Naga P. Chalasani

View on ClinicalTrials.gov

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.

Eligibility

Age

21 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individuals ≥ 21 years with a diagnosis of acute AH. The diagnosis of acute alcoholic hepatitis will be based on clinical features and testing including hepatomegaly, jaundice, fever, leukocytosis, compatible liver biochemistries in the context of heavy alcohol consumption. A liver biopsy is not mandatory, but will be required to confirm the diagnosis if a firm diagnosis of AH cannot be made on clinical and laboratory criteria
•Moderate severity defined as MELD score \> 11 and \< 20
•Heavy alcohol consumption (defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment)
•Written informed consent
•Negative urine pregnancy test where appropriate
•Women of child bearing potential should be willing to practice contraception throughout the treatment period

Exclusion Criteria

•Significant active infection (e.g., sepsis, or spontaneous bacterial peritonitis; SBP). Subjects can be reconsidered after the infection is under control.
•Serum creatinine \> 2.5 mg/dL
•Must not be receiving systemic steroids \> 1 week at the time of Screening or any experimental medicines for AH
•Presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. Patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable).
•Participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening

Locations (4)

Indiana University

Indianapolis, Indiana, United States

Mayo Clinic

Rochester, Minnesota, United States

Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Virgina Commonwealth University

Richmond, Virginia, United States

Key Dates

Start Date

November 3, 2014

Primary Completion Date

July 30, 2017

Completion Date

January 29, 2018

Last Updated

January 28, 2020

Enrollment

ACTUAL participants

Conditions

Alcoholic Hepatitis

Interventions

Placebo

DRUG

10 mg Obeticholic Acid (OCA)

DRUG

Short Course Steroids in Alcohol Associated Hepatitis

NCT06919458

Alcoholic Hepatitis

View study

NOT_YET_RECRUITINGPHASE3

PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

NCT06956482

Alcoholic Hepatitis

View study

COMPLETED

Alcoholic Hepatitis Network Observational Study

NCT03850899

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Short Course Steroids in Alcohol Associated Hepatitis

PROlonged Corticosteroid Treatment or N-ACetylcysteine for Severe Alcoholic Hepatitis

Alcoholic Hepatitis Network Observational Study

Complex Exploratory Study of Alcohol-Associated Hepatitis

Role of Extended Low Dose Prednisolone in Achieving Clinical and Biochemical Remission in Steroid Responsive Severe Alcoholic Hepatitis

Changes in gUt micRobiota After Enteral Feeding (in Alcoholic Hepatitis)