NCT01596335

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
4 years until next milestone

Results Posted

Study results publicly available

September 26, 2018

Completed
Last Updated

January 7, 2026

Status Verified

December 1, 2025

Enrollment Period

2.4 years

First QC Date

May 9, 2012

Results QC Date

January 23, 2018

Last Update Submit

December 15, 2025

Conditions

Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Keywords

InfliximabREMICADETA-650intravenous immunoglobulinKawasaki diseaseIVIG

Outcome Measures

Primary Outcomes (1)

  • Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration

    Up to 48hours

Secondary Outcomes (2)

  • Duration of Fever

    Up to Day56

  • Incidence of Coronary Artery Lesions

    Day 3, Day 7, Day14, Day 21, Day56

Study Arms (2)

TA-650

EXPERIMENTAL
Drug: TA-650

VGIH

ACTIVE COMPARATOR
Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)

Interventions

Polyethylene Glycol-treated Human Immunoglobulin (VGIH)DRUG

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.

VGIH
TA-650DRUG

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.

TA-650

Eligibility Criteria

Age1 Year - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Investigational site

Chugoku, Japan

Location

Investigational site

Chūbu, Japan

Location

Investigational site

Hokkaido, Japan

Location

Investigational site

Kanto, Japan

Location

Investigational site

Kyushu, Japan

Location

Investigational site

Shinetu, Japan

Location

Investigational site

Tōhoku, Japan

Location

Investigational site

Tōkai, Japan

Location

Related Publications (1)

  • 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.

    PMID: 29386515RESULT

MeSH Terms

Conditions

Mucocutaneous Lymph Node Syndrome

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesLymphatic DiseasesHemic and Lymphatic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Clinical Trials, Information Desk
Organization
Tanabe Pharma Corporation
cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

  • Masaaki Mori, MD

    Yokohama City University Medical Center

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 11, 2012

Study Start

May 1, 2012

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

January 7, 2026

Results First Posted

September 26, 2018

Record last verified: 2025-12

Locations

JP(8)