Hepatitis, Alcoholic Clinical Trial
Official title:
A Multicenter Randomized, Double-Blind, Placebo-controlled, Dosing, Safety and Efficacy Study of IMM 124-E (Hyperimmune Bovine Colostrum) for Patients With Severe Alcoholic Hepatitis
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.
Subjects with severe alcoholic hepatitis (20=> MELD <=28) about to receive prednisolone (40
mg/day x 28 days) will be randomized 1:1:1 to additionally receive either one of two doses of
IMM 124-E (2400 mg/day or 4800 mg/day) orally or placebo for the same duration. Standard of
care nutrition support and alcohol cessation recommendations will be provided to all
subjects. Alcohol withdrawal will be managed per standard of care. Subjects who meet Lille
criteria for failure of treatment on day 7 or side effects requiring discontinuation of
steroids will be removed from the study. The primary endpoint is a decrease in plasma
endotoxin levels.
The secondary endpoints will include:
1. Mechanistic endpoints: TNF-α, immune-inflammatory markers, microbiome-metagenome
2. Efficacy-related: number of subjects meeting Lille failure criteria at day 7 , mortality
(at 30 days, 90 days, and 180 days), time to drop in conjugated bilirubin by 50%, bile
acids, liver function tests, change in MELD, and sequential organ failure
3. Safety related: tolerability, adverse events.
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