Phase 2
N=57
Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
Hepatitis, Alcoholic
Bottom Line
View on ClinicalTrials.gov: NCT01968382 ↗Enrolled (actual)
57
Serious AEs
56.1%
Results posted
Jan 2020
Primary outcome: Primary: Gastrointestinal Safety Endpoints — 15; 27; 7; 14 Incidents
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- IMM 124-E (Hyperimmune Bovine Colostrum) (Drug); Placebo (High protein milk powder) (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gastrointestinal Safety Endpoints |
15; 27; 7; 14; 25; 18 | — |
| PRIMARY Combined Kidney, Brain, and Lung Safety Endpoints |
9; 10; 11; 0; 1; 0 | — |
| PRIMARY Infection Safety Endpoints |
2; 1; 2 | — |
| PRIMARY Other Safety Endpoints |
67; 113; 124 | — |
| SECONDARY Bowel Gastrointestinal Safety Endpoints |
— | — |
| SECONDARY Change in Circulating Endotoxin Levels |
-361.06; -72.94; 123.41 | 0.3198 |
| SECONDARY Lille Model Score |
5; 6; 9 | — |
| SECONDARY Mortality |
5; 2; 2 | — |
| SECONDARY Change in Liver Function |
-8.89; -6.82; -7.78 | 0.8462 |
| SECONDARY SOFA Score |
— | — |
| SECONDARY Change in Serum Bile Acids |
— | — |
| SECONDARY Time to 50% Drop in Bilirubin |
— | — |
| SECONDARY Cytokine Data |
— | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT01968382). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.