Clinical Trial: Study of Combined Therapy of Aspirin and "IVIG-SN" in Kawasaki Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Multicenter, Single-arm, Phase IV Study to Evaluate the Efficacy, Safety of Combined Therapy of Aspirin and High Dose "IVIG-SN" in Pediatric Patients With Kawasaki Dise
Brief Summary: The purpose of this study is to evaluate the safety, efficacy and of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with kawasaki diseases.
Detailed Summary:
This clinical trial was designed as a multicenter, single-arm, and open-label clinical trial.
Evaluate the incidence of coronary artery lesions in the 7th week of IVIG-SN administration, compared to the incidence of coronary artery lesions among untreated Kawasaki patients, to prove the superior efficacy of IVIG-SN.
Sponsor: Green Cross Corporation
Current Primary Outcome: Incidence of coronary artery lesions [ Time Frame: 7 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of coronary artery lesions [ Time Frame: 2weeks ]Incidence of coronary artery lesions in the 2nd week after IVIG-SN infusion
- Total fever duration [ Time Frame: baseline ]Total fever duration after IVIG-SN infusion
- variation of ESR, CRP, NT-proBNP,CK-MB [ Time Frame: baseline ]Evaluation in variation of ESR, CRP, NT-proBNP or BNP, and CK-MB
Original Secondary Outcome: Same as current
Information By: Green Cross Corporation
Dates:
Date Received: January 25, 2012
Date Started: January 2012
Date Completion:
Last Updated: September 19, 2012
Last Verified: January 2012