Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
Status:
Recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on
novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic
liver injury that has a short-term mortality rate much higher than that of other liver
diseases.
The primary objective of the study is to determine the clinical efficacy and safety of
Anakinra (plus zinc) compared to the current standard medical treatment consisting of
prednisone in participants with clinically severe AH. Key secondary objectives broadly are as
follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment
response; and (b) to develop novel endpoints to overcome the limitations of current
assessment strategies for severe AH.
Phase:
Phase 2
Details
Lead Sponsor:
Indiana University
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Treatments:
Interleukin 1 Receptor Antagonist Protein Lenograstim Prednisone Zinc