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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: Active Phase 2 study of Kawasaki Disease and Coronary Aneurysm, sponsored by Hawaii Pacific Health.

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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

We will assess the Z-score change (decrease of the Z-scores expressed as a positive number) of the coronary artery diameter measurements from the acute phase to the convalescent phase of the disease (average 4 weeks, range 3-8 weeks). Z-scores of the coronary arteries correspond to coronary artery diameter values measured in mm. A Z-score of 0 corresponds to the mean of the population. A Z-score higher than 0 corresponds to a coronary artery diameter larger than that of the mean. A Z-score exce

Interventions

  • DRUG Placebo
  • DRUG Doxycycline

Study Locations (1)

Hawaii

  • Kapiolani Medical Center for Women and Children - Honolulu

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2013-10
Est. Completion 2026-08
Phase Phase 2
Hawaii Pacific Health

7 total trials

What the registry record for NCT01917721 still lists

NCT01917721 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).

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 a single indexed study location in 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.

Similar trials for Kawasaki Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01917721's enrollment target sits among peer trials

50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01917721, the US trial registry maintained by the National Library of Medicine. NCT01917721 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.