drugset / Trial / NCT01968382
Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
Phase 2
Completed
57 enrolled
Virginia Commonwealth University
Immuron Ltd. · collabNational Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2014-12
- Primary completion
- 2018-12-22
- Completion
- 2018-12-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | IMM-124E | Protein / enzyme biologic | 2400 mg | Oral |
| Subject | IMM-124E | Protein / enzyme biologic | 4800 mg | Oral |