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

NCT01968382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-01-27

Study results available
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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.

Conditions

  • Hepatitis, Alcoholic

Interventions

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

Sponsors & Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

    collaborator NIH

  • Immuron Ltd.

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Arun J Sanyal, MBBS MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2018-12-22
Completion
2018-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968382 on ClinicalTrials.gov