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

NCT02039219 | Terminated Phase 2 Results DMC

• 5 other identifiers: TREAT 0021U01AA021840-01U01AA021883U01AA021891U01AA021788
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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).

  Baseline to 6 weeks (Day 42)

• MELD Score Change From Baseline 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.

  Baseline to 6 weeks (Day 42)

Secondary Outcomes (14)

• Any SAEs During the Follow-up Phase

  Days 42 to 180

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

  Baseline to 180 days

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

  Baseline to 180 days

• Change in MELD Score at 90 and 180 Days

  Days 90 and 180

• Change in Child-Pugh Score at Day 42, 90 and 180 Days

  Days 42, 90 and 180

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

10 mg Obeticholic Acid (OCA)

EXPERIMENTAL

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

Drug: 10 mg Obeticholic Acid (OCA)

Interventions

Placebo DRUG

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

Placebo

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.

Also known as: INT-747

10 mg Obeticholic Acid (OCA)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Naga P. Chalasani: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Intercept Pharmaceuticals: collaborator

Study Sites (4)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

Virgina Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Hepatitis, Alcoholic

Interventions

obeticholic acid

Condition Hierarchy (Ancestors)

Hepatitis; Liver Diseases; Digestive System Diseases; Liver Diseases, Alcoholic; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Results Point of Contact

• Title: Naga Chalasani, MD
• Organization: Indiana University School of Medicine

nchalasa@iu.edu

(317) 278-0414

Study Officials

• Naga Chalasani, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Naga Chalasani, MD, FACG

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 17, 2014
• Study Start: November 3, 2014
• Primary Completion: July 30, 2017
• Study Completion: January 29, 2018
• Last Updated: January 28, 2020
• Results First Posted: January 28, 2020

Record last verified: 2020-01

Locations

US (4)