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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:21 - Any
Updated:8/9/2018
Start Date:November 2014
End Date:June 29, 2018

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

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.


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
We found this trial at
4
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Naga Chalasani, MD
Phone: 317-278-1872
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Philadelphia, Pennsylvania 19141
Principal Investigator: Victor Navarro, MD
Phone: 215-456-8721
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Richmond, Virginia 23298
Principal Investigator: Arun J Sanyal, MD
Phone: 804-628-4395
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Richmond, VA
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Rochester, Minnesota 55905
Principal Investigator: Vijay Shah, MD
Phone: 507-284-2698
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Rochester, MN
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