A Study for Finding Optimal Indication for Cicrosporine A in Patients with Kawasaki Disease

Phase 4

Recruiting

• Conditions: Kawasaki Disease; Kawasaki disease, Children, Vasculitis, Coronary artery disease

• Registration Number: JPRN-jRCTs031230101
• Lead Sponsor: Hamada Hiromichi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-29
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

1) Pediatric patients with a diagnosis of KD according to the Kawasaki Disease Diagnostic Criteria (the 6th revised edition)23) (the 6th revised edition prepared by Kawasaki Disease Research Committee, the Ministry of Health, Labour and Welfare, 2020).
2)Age of between 4 months and 15 years at the time of signing the informed consent form
3) Inclusion in the study within 9 days of disease onset (considering day 1 to be the day when the fever develops)
4)Informed consent form signed by a legal guardian

Exclusion Criteria

1)Defervescence prior to enrollment
2)Suspicion that the symptoms may correspond to a disease other than KD (haemolytic streptococcal infection, EB virus infection, adenovirus infection Yersinia infection, measles, or Stevens-Johnson syndrome)
3)Initiation of IVIG treatment later than 9 days after disease onset
4)Having had treatment with tacrolimus (except external preparations), pitavastatin, rosuvastatin, bosentan, or aliskiren
5)History of hypersensitivity to CsA preparations, immunoglobulin preparations, or aspirin
6)Presence of an active bacterial infection: septicaemia, purulent meningitis, peritonitis or bacterial pneumonia
7)Treatment with other investigational drugs within 12 weeks of study commencement
8)Treatment with BCG vaccine or other live vaccine within 4 weeks of study commencement, or treatment with inactivated vaccine within 2 weeks of study commencement
9)Others: patients who are judged to be inappropriate for participants of the clinical study for safety reasons by the investigators or the sub-investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified