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| Sponsor: | University of California, San Diego |
|---|---|
| Collaborator: |
Centocor, Inc. |
| Information provided by: | University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00271570 |
Purpose
This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Kawasaki Disease |
Drug: Infliximab (Remicade) Biological: Intravenous immunoglobulin (IVIG) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Infliximab (Remicade) for Patients With Acute Kawasaki Disease Who Fail to Become Afebrile After Intravenous Gamma Globulin Therapy |
| Enrollment: | 24 |
| Study Start Date: | April 2004 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Second Dose of IVIG (2g/kg)
Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg)
|
Biological: Intravenous immunoglobulin (IVIG)
2nd dose of IVIG (2g/kg)
Other Name: Gammagard, Gamunex
|
|
Experimental: Infliximab (5mg/kg)
Remicade (5mg/kg) single dose
|
Drug: Infliximab (Remicade)
Remicade was 5 mg/kg IV (single dose)
|
This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
To be eligible for the trial, subjects must meet all of the following criteria:
Exclusion criteria
If a subject has any of the following criteria, he or she may not be enrolled in the study:
Contacts and Locations| United States, California | |
| Ucsd/Chhc | |
| San Diego, California, United States, 92103 | |
| Principal Investigator: | Jane C Burns, M.D. | UCSD/CHHC |
More Information
| Responsible Party: | Jane C. Burns, University of California, San Diego |
| ClinicalTrials.gov Identifier: | NCT00271570 History of Changes |
| Other Study ID Numbers: | 041374, 2004-0548 |
| Study First Received: | December 30, 2005 |
| Results First Received: | May 1, 2009 |
| Last Updated: | June 11, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Mucocutaneous Lymph Node Syndrome Vasculitis Vascular Diseases Cardiovascular Diseases Lymphatic Diseases Skin Diseases, Vascular Skin Diseases Immunoglobulins Antibodies Immunoglobulins, Intravenous |
Rho(D) Immune Globulin Infliximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Dermatologic Agents Therapeutic Uses Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |