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

Information source: Mitsubishi Tanabe Pharma Corporation
Information obtained from ClinicalTrials.gov on February 07, 2013
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: Recruiting

Sponsored by: Mitsubishi Tanabe Pharma Corporation

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

Overall contact:
Clinical Trial Information Desk, Email: cti-inq-ml@ml.mt-pharma.co.jp

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

Clinical Trial Information Desk, Email: cti-inq-ml@ml.mt-pharma.co.jp

Investigational site, Chugoku, Japan; Recruiting

Investigational site, Kanto, Japan; Recruiting

Investigational site, Kyushu, Japan; Recruiting

Additional Information

Starting date: May 2012
Last updated: December 20, 2012

Page last updated: February 07, 2013

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