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).

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.

Study Overview

• Status: Completed
• Conditions: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
• Intervention / Treatment: Drug: TA-650; Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • 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
    • Investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TA-650	Drug: TA-650; 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.
ACTIVE_COMPARATOR: VGIH	Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH); 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mitsubishi Tanabe Pharma Corporation
• Investigators: Study Director: Masaaki Mori, MD, Yokohama City University Medical Center

Publications and helpful links

General Publications

• Mori M, Hara T, Kikuchi M, Shimizu H, Miyamoto T, Iwashima S, Oonishi T, Hashimoto K, Kobayashi N, Waki K, Suzuki Y, Otsubo Y, Yamada H, Ishikawa C, Kato T, Fuse S. Infliximab versus intravenous immunoglobulin for refractory Kawasaki disease: a phase 3, randomized, open-label, active-controlled, parallel-group, multicenter trial. Sci Rep. 2018 Jan 31;8(1):1994. doi: 10.1038/s41598-017-18387-7.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): October 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: May 10, 2012
• First Posted (ESTIMATE): May 11, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 25, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: IVIG; Infliximab; Kawasaki disease; intravenous immunoglobulin; REMICADE; TA-650
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Lymphatic Diseases; Vasculitis; Skin Diseases, Vascular; Mucocutaneous Lymph Node Syndrome; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: TA-650-22