Status:
COMPLETED
Infliximab for Kawasaki Disease Patients Resistant to IVIG : a Multicentre, Prospective, Randomised Trial
Lead Sponsor:
Fudan University
Collaborating Sponsors:
Shanghai Children's Medical Center
Shanghai 10th People's Hospital
Conditions:
Kawasaki Disease
Eligibility:
All Genders
2-12 years
Phase:
PHASE3
Brief Summary
The objective of this study is to investigate the effect of infliximab to the children who don't respond to the first dose of intravenous immunoglobulin (IVIG) (2g/kg) in Kawasaki disease.
Detailed Description
Kawasaki disease(KD), the most common cause of acquired heart disease in developed countries, is a self-limited vasculitis that is treated with high doses of intravenous immunoglobulin. Resistance to ...
Eligibility Criteria
Inclusion
- (1)Individual patient's medical file data confirmed the diagnosis of KD using the 5th revised edition of diagnostic criteria for KD, issued by the Japan Kawasaki Disease Research Committee at the 7th International Kawasaki Disease Symposium in 2002.(2) Resistance to intravenous immunoglobulin in Kawasaki disease is defined as a temperature of 38.0°C or higher at 36 hours to 7 days after completion of the routine primary treatment .(3) the patients aged from 2 months to 12 years old. (4) All included patients required to sign an informed consent form
Exclusion
- . Exclusion criteria: (1) The patients with severe infections; (2) The patients with a history of tuberculosis or recent close contact with tuberculosis; (3) The patient vaccinated with live vaccine in 6 months; (4)The patients with the application of hormone or other immunosuppressive agents; (5) The patients didn"t want to signed informed consent.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02298062
Start Date
January 1 2013
End Date
September 1 2015
Last Update
February 3 2016
Active Locations (1)
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1
Children Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102