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NCT04747847 · ClinicalTrials.gov registry record · Early Phase 1
Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease
A Early Phase 1 study, sponsored by University of California, San Diego.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT04747847: Completed Early Phase 1 study, sponsored by University of California, San Diego.
NCT04747847 is a Early Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04747847, a Early Phase 1 study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart attack. Although we can identify children with KD that have these coronary artery abnormalities, there is no approved additional treatment to decrease coronary artery inflammation and arrest or prevent damage to the coronary arteries. Statins, a class of drugs that is known for lowering cholesterol, have also been shown to decrease inflammation in general as well as at the level of the vessel wall. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1) that leads to inflammation during acute KD, has been shown in the KD mouse model to prevent the development of coronary artery damage. Both of these therapies have been demonstrated to be safe and well-tolerated in KD patients. Therefore, we propose to study the effects of combination therapy with atorvastatin and anakinra in children with acute KD and early coronary artery abnormalities.
Primary Outcome
The number of participants with adverse events related to study drugs will be assessed and reported
Interventions
- DRUG Atorvastatin and anakinra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-06-22 |
| Est. Completion | 2022-08-17 |
| Phase | Early Phase 1 |
What the finished NCT04747847 record still lists
NCT04747847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin and anakinra is the first listed.
NCT04747847 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04747847 about?
NCT04747847 is a clinical study titled "Pilot Study of Atorvastatin and Anakinra in Children With Coronary Artery Abnormalities Secondary to Kawasaki Disease". Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the developed world. Despite available treatment, 25% of children in San Diego County appropriately treated for KD develop coronary artery abnormalities that could lead to complications later in life, including heart...
What is the current status of trial NCT04747847?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2019-06-22. Estimated completion is 2022-08-17.
What interventions are being tested in trial NCT04747847?
The interventions under investigation include: Atorvastatin and anakinra (DRUG).
Who is sponsoring clinical trial NCT04747847?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04747847's enrollment target sits among peer trials
5 1887th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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