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

Study Overview
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Brief Summary
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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.

Official Title
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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).

Conditions
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Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Intervention / Treatment
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* Drug: TA-650
* Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TA-650<br> | Drug: TA-650<br>* TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.<br>|
| Active Comparator: VGIH<br> | Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)<br>* VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration |  | Up to 48hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Fever |  | Up to Day56 | 
| Incidence of Coronary Artery Lesions |  | Day 3, Day 7, Day14, Day 21, Day56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TA-650, intravenous immunoglobulin, Kawasaki disease, IVIG, Infliximab, REMICADE