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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-03

Study Completion Date

2018-01-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Alcoholic Hepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.

10 mg Obeticholic Acid (OCA)

10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily for 6 weeks.

Group Type EXPERIMENTAL

10 mg Obeticholic Acid (OCA)

Intervention Type DRUG

10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.

Interventions

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Placebo

1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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INT-747

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No