search
Back to results

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

Primary Purpose

Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
TA-650
Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin focused on measuring Infliximab, REMICADE, TA-650, intravenous immunoglobulin, Kawasaki disease, IVIG

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site
  • Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TA-650

VGIH

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Duration of Fever
Incidence of Coronary Artery Lesions

Full Information

First Posted
May 9, 2012
Last Updated
September 28, 2018
Sponsor
Mitsubishi Tanabe Pharma Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01596335
Brief Title
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Keywords
Infliximab, REMICADE, TA-650, intravenous immunoglobulin, Kawasaki disease, IVIG

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-650
Arm Type
Experimental
Arm Title
VGIH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
TA-650
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Intervention 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.
Primary Outcome Measure Information:
Title
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
Time Frame
Up to 48hours
Secondary Outcome Measure Information:
Title
Duration of Fever
Time Frame
Up to Day56
Title
Incidence of Coronary Artery Lesions
Time Frame
Day 3, Day 7, Day14, Day 21, Day56

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaaki Mori, MD
Organizational Affiliation
Yokohama City University Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Chubu
Country
Japan
Facility Name
Investigational site
City
Chugoku
Country
Japan
Facility Name
Investigational site
City
Hokkaido
Country
Japan
Facility Name
Investigational site
City
Kanto
Country
Japan
Facility Name
Investigational site
City
Kyushu
Country
Japan
Facility Name
Investigational site
City
Shinetu
Country
Japan
Facility Name
Investigational site
City
Tohoku
Country
Japan
Facility Name
Investigational site
City
Tokai
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29386515
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs