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NCT01968382 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
A Phase 2 study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
NCT01968382 is a Phase 2 study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 57 participants.
The verdict
NCT01968382, a Phase 2 study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
Study 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.
Interventions
- DRUG IMM 124-E (Hyperimmune Bovine Colostrum)
- DRUG Placebo (High protein milk powder)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2014-12 |
| Est. Completion | 2018-12-22 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01968382
The ClinicalTrials.gov registry entry for NCT01968382 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IMM 124-E (Hyperimmune Bovine Colostrum) is the first listed.
NCT01968382 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01968382 about?
NCT01968382 is a clinical study titled "Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis". 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 ...
What is the current status of trial NCT01968382?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2014-12. Estimated completion is 2018-12-22.
What interventions are being tested in trial NCT01968382?
The interventions under investigation include: IMM 124-E (Hyperimmune Bovine Colostrum) (DRUG), Placebo (High protein milk powder) (DRUG).
Who is sponsoring clinical trial NCT01968382?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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