Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis (TREAT)
Hepatitis, Alcoholic
About this trial
This is an interventional treatment trial for Hepatitis, Alcoholic focused on measuring IMM 124-E, Bovine Colostrum, Alcoholic, Hepatitis, LPS, Hyper-immune
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.
Sites / Locations
- Indiana University
- Mayo Clinic
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
IMM 124-E 2400 mg/day
IMM 124-E 4800 mg/day
Placebo (High protein milk powder)
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.