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NCT01917721 · ClinicalTrials.gov registry record · Phase 2
Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease
A Phase 2 study of Kawasaki Disease and Coronary Aneurysm, sponsored by Hawaii Pacific Health.
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01917721 is a Phase 2 study of Kawasaki Disease and Coronary Aneurysm that is active but no longer recruiting, run by Hawaii Pacific Health. The registered enrollment target is 50 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01917721, a Phase 2 study of Kawasaki Disease and Coronary Aneurysm, is active but no longer recruiting, sponsored by Hawaii Pacific Health.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and blood vessels including the coronary arteries of the heart. Despite the currently available therapy, about one third of children develop enlargement of the coronary arteries that can lead to serious complications such as coronary artery stenosis, heart attack and even death. Kawasaki disease is the most common heart disease in children in the USA and it is especially common among the children of Hawaii. Every year, 50-90 children are diagnosed with KD in Hawaii and unfortunately there is no medication available to successfully prevent coronary artery damage in a subset of cases. During the first few weeks of the illness, cells of the immune system attack the coronary arteries and release a special substance (MMP) that is responsible for the coronary artery enlargement. There is a common antibiotic, doxycycline that can specifically block the action of this special substance (MMP). Research done on animals with KD showed that doxycycline was able to block this special substance and prevent enlargement of coronary arteries. Research in adults with enlargement of the main artery in their abdomen also showed that doxycycline may improve the outcome. Based on these studies doxycycline may be a promising therapy for children with KD, who develop enlargement of the coronary arteries. The investigators' proposed research study will assess the usefulness of doxycycline in preventing the progressive enlargement of coronary arteries in children with KD. The investigators plan to perform a small (pilot) study to evaluate how good is doxycycline in preventing coronary artery enlargement. The investigators will treat 50 children with KD and enlarged coronary arteries for three weeks with doxycycline and assess the change in coronary arteries as well as the blood levels of the special substance (MMP). If doxycycline proves to be beneficial in this small study, the investigators are goi
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Doxycycline
Study Locations (1)
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2013-10 |
| Est. Completion | 2026-08 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01917721
The ClinicalTrials.gov registry entry for NCT01917721 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hawaii Pacific Health, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Kawasaki Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01917721 reports 1 study location spanning 1 distinct geographic area - top geographies include Hawaii.
Frequently Asked Questions
What is clinical trial NCT01917721 about?
NCT01917721 is a clinical study titled "Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease". Kawasaki disease (KD) affects infants and young children causing inflammation of the skin and blood vessels including the coronary arteries of the heart. Despite the currently available therapy, about one third of children develop enlargement of the coronary arteries that can lead to serious complic...
What is the current status of trial NCT01917721?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2013-10. Estimated completion is 2026-08.
What conditions does trial NCT01917721 study?
This clinical trial studies the following conditions: Kawasaki Disease, Coronary Aneurysm.
What interventions are being tested in trial NCT01917721?
The interventions under investigation include: Placebo (DRUG), Doxycycline (DRUG).
Who is sponsoring clinical trial NCT01917721?
This trial is sponsored by Hawaii Pacific Health, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01917721 being conducted?
This trial has 1 study location across Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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