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NCT01809132 · ClinicalTrials.gov registry record · Phase 2
Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis
A Phase 2 study of Acute Alcoholic Hepatitis, sponsored by Mack Mitchell.
- Completed
- Registry status
- Phase 2
- Development phase
- 104
- Enrollment target
- 4
- Study locations
NCT01809132 is a Phase 2 study of Acute Alcoholic Hepatitis that has completed, run by Mack Mitchell. The registered enrollment target is 104 participants. The trial reports 4 study locations across 4 states.
The verdict
NCT01809132, a Phase 2 study of Acute Alcoholic Hepatitis, has completed, sponsored by Mack Mitchell.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 104 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone). This will be compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will be treated and followed for 6 months and the two treatment groups will be compared for differences in death rates and laboratory tests that measure liver and gut function.
Conditions Studied
Interventions
- DRUG Pentoxifylline
- DRUG Methylprednisolone
- DRUG Anakinra
- DRUG Zinc Sulfate
Study Locations (4)
Kentucky
- University of Louisville - Louisville
Massachusetts
- University of Massachusetts Medical School - Worcester
Ohio
- Cleveland Clinic - Cleveland
Texas
- University of Texas Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2013-09 |
| Est. Completion | 2018-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01809132
The ClinicalTrials.gov registry entry for NCT01809132 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mack Mitchell, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Acute Alcoholic Hepatitis appearing as the primary indexed condition, and to 4 interventions - of which Pentoxifylline is the first listed.
NCT01809132 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Kentucky, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT01809132 about?
NCT01809132 is a clinical study titled "Efficacy Study of Anakinra, Pentoxifylline, and Zinc Compared to Methylprednisolone in Severe Acute Alcoholic Hepatitis". This study will compare two different treatments of acute alcoholic hepatitis. The current standard of care is treatment with corticosteroids (methylprednisolone). This will be compared to treatment with anakinra, pentoxifylline, plus zinc sulfate. The participants will be treated and followed for 6...
What is the current status of trial NCT01809132?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 104 participants. The study started on 2013-09. Estimated completion is 2018-10.
What conditions does trial NCT01809132 study?
This clinical trial studies the following conditions: Acute Alcoholic Hepatitis.
What interventions are being tested in trial NCT01809132?
The interventions under investigation include: Pentoxifylline (DRUG), Methylprednisolone (DRUG), Anakinra (DRUG), Zinc Sulfate (DRUG).
Who is sponsoring clinical trial NCT01809132?
This trial is sponsored by Mack Mitchell, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01809132 being conducted?
This trial has 4 study locations across Kentucky, Massachusetts, Ohio, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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