Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
Condition: Hepatitis, Alcoholic
MeSH terms: Hepatitis A; Hepatitis; Hepatitis, Alcoholic
Intervention: IMM 124-E (Hyperimmune Bovine Colostrum); Placebo (High protein milk powder)
Intervention description: Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.; Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: IMM 124-E; Bovine Colostrum; Alcoholic; Hepatitis; LPS; Hyper-immune

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.
    

Eligibility 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.