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 ]

Incidence of coronary artery lesions in the 7 weeks after IVIG-SN infusion


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