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NCT04072822 · ClinicalTrials.gov registry record · Phase 2
Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 147
- Enrollment target
NCT04072822: Completed Phase 2 study, sponsored by Indiana University.
NCT04072822 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 147 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04072822, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 147 participants
- Enrollment target
Study Summary
This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary objective of the study is to determine the clinical efficacy and safety of Anakinra (plus zinc) compared to the current standard medical treatment consisting of prednisone in participants with clinically severe AH. Key secondary objectives broadly are as follows: (a) to evaluate the use of biomarkers to assess disease severity and treatment response; and (b) to develop novel endpoints to overcome the limitations of current assessment strategies for severe AH.
Primary Outcome
The primary analysis will be comparisons of 90-day mortality of Prednisone and Anakinra plus zinc vs Prednisone.
Interventions
- DRUG Prednisone
- DRUG Placebos
- DRUG Anakinra and Zinc
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2022-08-12 |
| Phase | Phase 2 |
What the finished NCT04072822 record still lists
NCT04072822 is an interventional study that assigns participants to a tested intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (11% higher).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT04072822 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04072822 about?
NCT04072822 is a clinical study titled "Trial of Anakinra (Plus Zinc) or Prednisone in Patients With Severe Alcoholic Hepatitis". This multicenter, randomized, double blinded, placebo-controlled clinical trial is focused on novel treatments for severe alcoholic hepatitis (AH), a life-threatening stage of alcoholic liver injury that has a short-term mortality rate much higher than that of other liver diseases. The primary obje...
What is the current status of trial NCT04072822?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 147 participants. The study started on 2020-07-10. Estimated completion is 2022-08-12.
What interventions are being tested in trial NCT04072822?
The interventions under investigation include: Prednisone (DRUG), Placebos (DRUG), Anakinra and Zinc (DRUG).
Who is sponsoring clinical trial NCT04072822?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04072822's enrollment target sits among peer trials
147 495th of 2000 higher than 1,505 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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