Kawasaki Disease
Conditions
Interventions
This study is a Phase I 3+3 design in which 3 subjects will be given the first dose (0.125mg/kg/day) and, if there are no dose-limiting toxicities (DLT) after 6 weeks of therapy, the next 3 subjects w
Sponsors
Kobayashi Tohru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patienbts aged 2 to 17 years old 2) Meets clinical criteria for KD according to AHA guidelines and clinical criteria with LAD/RCA z-score 2.5 and over or an aneurysm of one of the coronary arteries 3) Patient presents within the first 20 days after fever onset 4) Parent or legal guardian able and willing to provide informed consent and subject willing and able to provide assent when appropriate
Exclusion criteria
Exclusion criteria: 1) Use of a statin, fibrate, or niacin within the 3 months prior to enrollment 2) Have any chronic disease, except asthma, atopic dermatitis, autism or controlled seizure disorder 3) Screening creatine phosphokinase (CK) more than 3 times upper limit of normal for age 4) Screening total cholesterol 99mg/dL and under 5) Screening AST or ALT 76IU/L and over 6) Patient taking a CYP3A4 inhibitor (i.e. cyclosporine, clarithromycin or doxycycline) in the last 7 days 7) Patient has a history of allergy to atorvastatin or its derivatives 8) Pregnant, unwilling to practice contraception during the study, or lactating female
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of atorvastatin in the study population | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pharmacokinetics of atorvastatin 2.Activity of atorvastatin | — |
Contacts
Public ContactTohru Kobayashi
National Center for Child Health and Development
Outcome results
None listed