Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT01596335
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with Kawasaki disease (incipient cases only) with 5 or more of the 6 major symptoms of Kawasaki disease.
* Patients refractory to initial IVIG therapy (a single administration at 2 g per kg body weight).
* Patients with a fever of 37.5ºC or higher axillary temperature at the time of enrollment.
* Patients to whom the study drug can be administered by day 8 of disease.
Exclusion Criteria:
* Patients who have received vaccination with Bacille Calmette-Guérin (BCG) vaccine within 6 months before the enrollment.
* Patients with a complication, or a history within 6 months before the enrollment of, serious infections requiring hospitalization.
* Patients with a complication, or a history within 6 months before the enrollment of, opportunistic infections.
* Patients complicated with active tuberculosis, active hepatitis B or C, or patients confirmed to be hepatitis B virus carriers or a history of hepatitis B.
* Patients confirmed to have HIV infection, or patients with a family history of HIV infection.
* Patients who have a history of receiving treatment with infliximab or other biological products.
* Patients who had participated in another clinical study and had received a study drug within 12 weeks before giving consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
10 Years
Study:
NCT01596335
Study Brief:
Protocol Section:
NCT01596335