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NCT00841789 · ClinicalTrials.gov registry record · Phase 2
A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease
A Phase 2 study of Kawasaki Disease and Mucocutaneous Lymph Node Syndrome, sponsored by Michael Portman.
- Completed
- Registry status
- Phase 2
- Development phase
- 205
- Enrollment target
- 8
- Study locations
NCT00841789: Completed Phase 2 study of Kawasaki Disease and Mucocutaneous Lymph Node Syndrome, sponsored by Michael Portman.
NCT00841789 is a Phase 2 study of Kawasaki Disease and Mucocutaneous Lymph Node Syndrome that has completed, run by Michael Portman. The registered enrollment target is 205 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841789, a Phase 2 study of Kawasaki Disease and Mucocutaneous Lymph Node Syndrome, has completed, sponsored by Michael Portman.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 205 participants
- Enrollment target
- 8
- Study locations
Study Summary
The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD
Primary Outcome
The primary outcome is the proportion of subjects who become refractory to IVIG. Subjects requiring 1 dose of IVIG are classified as responders and subjects requiring more than 1 dose are classified as IVIG refractory.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Etanercept
Study Locations (8)
New York
- Feinstein Institute for Medical Rsearch - New Hyde Park
- Columbia University Medical Center - New York
- Montefiore Medical Center - The Bronx
Texas
- Texas Children's Hospital - Houston
Utah
- Primary Children's Medical Center - Salt Lake City
Washington
- Seattle Children's Hospital - Seattle
Wisconsin
- Children's Hospital of Wisconsin - Milwaukee
Quebec
- Sainte-Justine Hospital - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2009-03 |
| Est. Completion | 2018-08-30 |
| Phase | Phase 2 |
What the finished NCT00841789 record still lists
NCT00841789 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% higher).
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.
NCT00841789 lists 8 locations in 6 states (New York, Texas, Utah).
Frequently Asked Questions
What is clinical trial NCT00841789 about?
NCT00841789 is a clinical study titled "A Randomized, Double Blind, Placebo Controlled Study of Etanercept in Children With Kawasaki Disease". The purpose of this study is to determine whether Etanercept (Enbrel) when used in conjunction with IVIG and aspirin, improves treatment response to IVIG in patients with Kawasaki Disease. Funding Source- FDA/OOPD
What is the current status of trial NCT00841789?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 205 participants. The study started on 2009-03. Estimated completion is 2018-08-30.
What conditions does trial NCT00841789 study?
This clinical trial studies the following conditions: Kawasaki Disease, Mucocutaneous Lymph Node Syndrome.
What interventions are being tested in trial NCT00841789?
The interventions under investigation include: Placebo (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT00841789?
This trial is sponsored by Michael Portman, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00841789 being conducted?
This trial has 8 study locations across New York, Texas, Utah, Washington, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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 NCT00841789's enrollment target sits among peer trials
205 298th of 2000 higher than 1,702 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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