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Infliximab Plus Intravenous Immunoglobulin for the Primary Treatment of Kawasaki Disease

NCT00760435 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2014-11-24

Study results available
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Summary

The purpose of this study is to determine whether the addition of infliximab to standard primary therapy of intravenous immunoglobulin (IVIG) and high dose aspirin will reduce resistance to therapy in acute Kawasaki disease (KD).

Conditions

  • Kawasaki Disease

Interventions

DRUG

Infliximab

5 mg/kg IV over 2 hours once

DRUG

Placebo

Placebo (same volume as active drug)

Sponsors & Collaborators

Principal Investigators

  • Jane C Burns, M.D. · University of California, San Diego

  • Adriana H. Tremoulet, M.D. · University of California, San Diego

  • Octavio Ramilo, M.D. · University of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760435 on ClinicalTrials.gov