NCT01968382

Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Hepatitis, Alcoholic

Interventions

Type	Name	Description
DRUG	IMM 124-E (Hyperimmune Bovine Colostrum)	Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
DRUG	Placebo (High protein milk powder)	Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily

Timeline

• Start date: 2014-12-01
• Primary completion: 2018-12-22
• Completion: 2018-12-22
• First posted: 2013-10-24
• Last updated: 2020-01-27
• Results posted: 2020-01-27

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study