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

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).

Sponsors

Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Source Mitsubishi Tanabe Pharma Corporation
Brief 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.

Overall Status Completed
Start Date May 2012
Completion Date October 2014
Primary Completion Date October 2014
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration Up to 48hours
Secondary Outcome
Measure Time Frame
Duration of Fever Up to Day56
Incidence of Coronary Artery Lesions Day 3, Day 7, Day14, Day 21, Day56
Enrollment 31
Condition
Intervention

Intervention Type: Drug

Intervention Name: TA-650

Description: 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.

Arm Group Label: TA-650

Intervention Type: Drug

Intervention Name: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)

Description: 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.

Arm Group Label: VGIH

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.

Gender: All

Minimum Age: 1 Year

Maximum Age: 10 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Masaaki Mori, MD Study Director Yokohama City University Medical Center
Location
Facility:
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
Location Countries

Japan

Verification Date

September 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: TA-650

Type: Experimental

Label: VGIH

Type: Active Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov