Pilot study to assess efficacy and safety of Cyclosporine for refractory Kawasaki disease
Phase 2
Recruiting
- Conditions
- Kawasaki Disease
- Registration Number
- JPRN-UMIN000002032
- Lead Sponsor
- Study group for search of susceptibility genes of Kawasaki disease and implementation of genotype-based personalized medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Not provided
Exclusion Criteria
1.Recurrent cases of KD 2.Patients having received initial IVIG on the eighth day or later of illness 3.Patients with coronary artery lesions before starting initial IVIG 4.Patients being afebrile before starting initial IVIG 5.Patients having received steroids and/or immunosuppressive agents within a month 6.Patients having received IVIG within 6 month 7.Patients with drug allergy or idiosyncrasy 8.Patients with other severe diseases 9.Patients with severe hepatic dysfunction when starting CyA therapy. 10.Patients with severe renal dysfunction when starting CyA therapy 11.Patients whose doctors think their participation in this study inappropriate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of coronary artery lesions abnormalities
- Secondary Outcome Measures
Name Time Method Duration of fever under CyA treatment Duration to normalization of CRP levels % Neutrophils Incidence of adverse reaction