Clinical Trial: Study of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Steroid Therapy
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Patients With Severe Alcoholic Hepatitis and Contraindications to Corticosteroid Therapy
Brief Summary: The main purpose of the study is to test if taking a study drug called emricasan (also known as IDN-6556 and PF-03491390) will affect overall patient survival after one month of treatment.
Detailed Summary: The study will also see if overall patient survival is affected at 6 months, and if the study drug improves liver function.
Sponsor: Conatus Pharmaceuticals Inc.
Current Primary Outcome: Survival [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
- Survival [ Time Frame: 6 months ]
- Change in liver function scores [ Time Frame: 28 days ]
- Worsening of pre-existing organ failure or development of new organ failure [ Time Frame: 28 days ]
Information By: Conatus Pharmaceuticals Inc.
Dates:
Date Received: July 29, 2013
Date Started: July 2013
Date Completion:
Last Updated: September 16, 2016
Last Verified: September 2016
