Phase 3
Completed N=31
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Source: ClinicalTrials.gov NCT01596335 ↗
Enrolled (actual)
31
Serious AEs
3.2%
Results posted
Sep 2018
Primary outcomePrimary: Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration — 75.0; 33.3 percentage of patients
◆ Published Evidence
Established
80citations · ~10 / year
Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial.
Summary
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.
Linked Publications
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Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration |
75.0; 33.3 | — |
| SECONDARY Duration of Fever |
16.00; 42.20; 13.90; 25.90 | — |
| SECONDARY Incidence of Coronary Artery Lesions |
0; 12.5; 0; 14.3; 0; 16.7 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01596335) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.