Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease

Tanabe Pharma Corporation

Status and phase

Completed

Phase 3

Conditions

Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Treatments

Drug: TA-650

Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01596335

TA-650-22

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of TA-650 in comparison with a control drug Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in patients with Kawasaki disease refractory to initial therapy with Intravenous Immunoglobulin (IVIG). The pharmacokinetics of TA-650 is also examined.

Enrollment

31 patients

Sex

All

Ages

1 to 10 years old

Volunteers

No Healthy Volunteers

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.