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



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:21 - Any
Updated:3/30/2019
Start Date:December 2014
End Date:December 22, 2018

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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.

Inclusion Criteria:

- Alcoholic hepatitis

- Men and women age 21 and above

- MELD >= 20 but <=28

- About to initiate prednisolone treatment, < 7 days of steroid treatment, or treatment
naive.

- Actively consuming alcohol within 6 weeks of entry into the study

- Willing and able to comply with study requirements (including contraception)

- Subjects or their legally authorized representative (LAR) who have provided voluntary
written informed consent.

Exclusion Criteria:

- Failure to obtain informed consent

- Subjects who are known to be HIV positive

- Active infection or sepsis (pneumonia by X-ray, positive blood or urine culture) or
multi-organ failure

- Other or concomitant liver disease present: viral hepatitis, autoimmune liver disease,
metabolic liver disease, vascular liver disease

- Cow milk allergy or severe lactose intolerance

- Active GI bleeding

- Untreated spontaneous bacterial peritonitis based on >250 polymorphonuclear cells or
positive culture

- Acute kidney injury at time of randomization with Creatinine > 1.5 md/dL

- Evidence of acute pancreatitis (by imaging and lipase) or biliary obstruction (dilated
bile ducts)

- Subjects who are pregnant or lactating

- Significant systemic or major illness, that, in the opinion of the Investigator would
preclude the patient from participating in and completing the study

- Patients requiring the use of vasopressors or inotropic support in 12 hours prior to
randomization

- Treatment for alcoholic hepatitis within 1 month of study entry with corticosteroids
use>1 week immediately prior to the time of entry into the study.

- Any patient who has received any investigational drug or device within 30 days of
dosing or who is scheduled to receive another investigational drug or device in the
course of the study.
We found this trial at
3
sites
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Arun J Sanyal, MBBS MD
Phone: 804-828-9311
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Naga Chalasani, MD
Phone: 317-278-1872
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Rochester, Minnesota 55905
Principal Investigator: Vijay Shah, MD
Phone: 507-284-2638
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