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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 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 147 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04072822
The ClinicalTrials.gov registry entry for NCT04072822 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 147 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Indiana University, which has 890 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT04072822 reports 0 study locations.
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.
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