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

• Status: Completed
• Trial end date: 2018-12-22
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborators: Immuron Ltd.; National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Criteria

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.