Different Doses of IVIG for Kawasaki Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

404

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

March 31, 2016

Study Completion Date

September 30, 2016

Conditions
Kawasaki Disease
Interventions
DRUG

IVIG (1g/kg,once)

"Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.~Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once."

DRUG

IVIG (1g/kg,twice)

"Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.~Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once."

DRUG

IVIG (2g/kg.once)

"Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.~Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once."

Trial Locations (1)

201102

Children Hospital of Fudan University, Shanghai

All Listed Sponsors
collaborator

Shanghai Children's Medical Center

OTHER

collaborator

Shanghai Children's Hospital

OTHER

lead

Children's Hospital of Fudan University

OTHER

NCT02439996 - Different Doses of IVIG for Kawasaki Disease | Biotech Hunter | Biotech Hunter