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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: Completed Phase 2 study of Acute Alcoholic Hepatitis, sponsored by Mack Mitchell.
NCT01809132 is a Phase 2 study of Acute Alcoholic Hepatitis that has completed, run by Mack Mitchell. The registered enrollment target is 104 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Death at 180 days
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 |
What the finished NCT01809132 record still lists
NCT01809132 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (22% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01809132's enrollment target sits among peer trials
104 660th of 2000 higher than 1,337 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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