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

Information source: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Intervention: TA-650 (Drug); Polyethylene Glycol-treated Human Immunoglobulin (VGIH) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Mitsubishi Tanabe Pharma Corporation

Official(s) and/or principal investigator(s):
Masaaki Mori, MD, Study Director, Affiliation: Yokohama City University Medical Center

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.

Clinical Details

Official title: 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).

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Defervescence rate within 48 hours after the start of the study drug administration

Secondary outcome:

Duration of fever

Incidence of coronary artery lesions

Eligibility

Minimum age: 1 Year. Maximum age: 10 Years. Gender(s): Both.

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.

Locations and Contacts

Investigational site, Chubu, Japan

Investigational site, Chugoku, Japan

Investigational site, Hokkaido, Japan

Investigational site, Kanto, Japan

Investigational site, Kyushu, Japan

Investigational site, Shinetu, Japan

Investigational site, Tohoku, Japan

Investigational site, Tokai, Japan

Additional Information

Starting date: May 2012
Last updated: April 9, 2015

Page last updated: August 23, 2015

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