Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
Status:
Completed
Trial end date:
2018-12-22
Target enrollment:
Participant gender:
Summary
Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS
antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters
related to severe alcoholic hepatitis (SAH).
IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids.
Aim: To perform a phase 2a "proof of concept" placebo-controlled, dose-ranging study of Imm
124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on
steroids.
Phase:
Phase 2
Details
Lead Sponsor:
Virginia Commonwealth University
Collaborators:
Immuron Ltd. National Institute on Alcohol Abuse and Alcoholism (NIAAA)