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NCT02780583 · ClinicalTrials.gov registry record · Phase 1
Treatment of Macrophage Activation Syndrome (MAS) With Anakinra
A Phase 1 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT02780583: Clinical Trial Phase 1 study, sponsored by University of Alabama at Birmingham.
NCT02780583 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02780583, a Phase 1 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The primary purpose of this study is to determine whether giving injections of anakinra is a safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for patients who are admitted to the hospital with signs of severe inflammation (macrophage activation syndrome) that is potentially life-threatening. Anakinra is a commercially available product (Kineret™) approved for the treatment of rheumatoid arthritis; it is a replica of a naturally occurring protein called Il-1 receptor antagonist (IL-1ra), made by humans to inhibit and regulate the action of interleukin-1 (IL-1). IL-1 is a mediator of inflammation that when generated in excess amounts by immune system cells can result in severe dysfunction of multiple organs that can be life-threatening. The specific primary objectives of the study are to determine if giving anakinra results in no increased infection complications or mortality. Additional data will be collected to determine whether anakinra administration results in any other unanticipated side effects in this setting, and the effects of anakinra administration on inflammation markers, the overall dose of steroids required to treat the inflammation, and the length of hospital stay.
Primary Outcome
The primary outcome measure is to determine whether hospital acquired infections or deaths are increased when anakinra is added to corticosteroid use during the first 72 hours of MAS management
Interventions
- DRUG placebo
- DRUG kineret
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2016-05-15 |
| Est. Completion | 2024-04-30 |
| Phase | Phase 1 |
Why NCT02780583 stopped before completion
NCT02780583 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02780583 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02780583 about?
NCT02780583 is a clinical study titled "Treatment of Macrophage Activation Syndrome (MAS) With Anakinra". The primary purpose of this study is to determine whether giving injections of anakinra is a safe and well tolerated treatment to give as an adjunct to standard prescribed treatment for patients who are admitted to the hospital with signs of severe inflammation (macrophage activation syndrome) that ...
What is the current status of trial NCT02780583?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2016-05-15. Estimated completion is 2024-04-30.
What interventions are being tested in trial NCT02780583?
The interventions under investigation include: placebo (DRUG), kineret (DRUG).
Who is sponsoring clinical trial NCT02780583?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02780583's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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