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

Phase 2TerminatedNCT02039219

Naga P. Chalasani19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alcoholic Hepatitis

Interventions

PlaceboDRUG

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

10 mg Obeticholic Acid (OCA)DRUG

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

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

MELD Score Mean(SD)

The Model for End-Stage Liver Disease (MELD) is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.

Time frame: Baseline to 6 weeks (Day 42)

Incidence of Serious Adverse Events (SAEs) During the Treatment Phase

Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).

Time frame: Baseline to 6 weeks (Day 42)

MELD Score Change From Baseline Mean(SD)

Time frame: Baseline to 6 weeks (Day 42)

Secondary Outcomes

Any SAEs During the Follow-up Phase

Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).

Time frame: Days 42 to 180

SAEs Attributable to the Study Medicine During the Treatment and Follow-up Phases

Number of subjects with one or more SAE are reported in relation to study medication (not related, unlikely, possible, probable, definite).

Time frame: Baseline to 180 days

Adverse Events (AEs) During the Treatment and Follow-up Phases

Number of subjects with one or more AEs are reported in relation to study medication (not related, unlikely, possible, probable, definite).

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.