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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Naga P. Chalasani

Current Primary Outcome:

  • Change in MELD score at 6 weeks [ Time Frame: baseline to 6 weeks ]
  • Incidence of serious adverse events (SAEs) during the treatment phase [ Time Frame: baseline to 6 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Any SAEs during the follow-up phase [ Time Frame: Days 42 to 180 ]
  • SAEs attributable to the study medicine during the treatment and follow-up phases [ Time Frame: Days 42 to 180 ]
  • Adverse events (AEs) and discontinuation rates during the treatment and follow-up phases [ Time Frame: days 42 to 180 ]
  • Change in MELD score at 90 and 180 days [ Time Frame: day 90 and 180 ]
  • Change in Child-Pugh score at 6 weeks and at 90 and 180 days [ Time Frame: Day 90 and 180 ]
  • Mortality rate at Week 6 and at 90 and 180 days [ Time Frame: Week 6 and Days 90 and 180 ]
  • Rates of hospitalization [ Time Frame: baseline to day 180 ]
  • Changes in intestinal inflammation [ Time Frame: baseline to day 180 ]
  • Changes in serum oxidative stress. [ Time Frame: baseline to day 180 ]
  • Length of hospital stays [ Time Frame: Baseline to 180 days ]
  • Changes in bacterial translocation [ Time Frame: baseline to 180 days ]
  • Changes in cytokines [ Time Frame: baseline to 180 days ]
  • Changes in activation of innate immunity [ Time Frame: baseline to 180 days ]


Original Secondary Outcome:

  • Any SAEs during the follow-up phase [ Time Frame: Days 42 to 180 ]
  • SAEs attributable to the study medicine during the treatment and follow-up phases [ Time Frame: Days 42 to 180 ]
  • Adverse events (AEs) and discontinuation rates during the treatment and follow-up phases [ Time Frame: days 42 to 180 ]
  • Change in MELD score at 90 and 180 days [ Time Frame: day 90 and 180 ]
  • Change in Child-Pugh score at 6 weeks and at 90 and 180 days [ Time Frame: Day 90 and 180 ]
  • Mortality rate at Week 6 and at 90 and 180 days [ Time Frame: Week 6 and Days 90 and 180 ]
  • Rates of hospitalization and lengths of stay [ Time Frame: baseline to day 180 ]
  • Changes in intestinal permeability [ Time Frame: baseline to day 180 ]
  • Changes in intestinal inflammation and bacterial translocation [ Time Frame: baseline to day 180 ]
  • Changes in hepatic CYP2E1 activity [ Time Frame: baseline to day 180 ]
  • Changes in serum oxidative stress, cytokines, and activation of innate immunity. [ Time Frame: baseline to day 180 ]


Information By: Indiana University

Dates:
Date Received: January 15, 2014
Date Started: November 2014
Date Completion: December 2018
Last Updated: February 3, 2017
Last Verified: February 2017