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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 is a Early Phase 1 study that has completed, run by University of California, San Diego. The registered enrollment target is 5 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04747847
The ClinicalTrials.gov registry entry for NCT04747847 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Diego, which has 775 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Atorvastatin and anakinra is the first listed.
NCT04747847 reports 0 study locations.
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.
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