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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 is a Phase 1 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 9 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02780583
The ClinicalTrials.gov registry entry for NCT02780583 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT02780583 reports 0 study locations.
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.
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