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

This study is currently recruiting participants.
Verified December 2012 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01596335
First received: May 9, 2012
Last updated: December 20, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
 Drug: TA-650
Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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).

Resource links provided by NLM:

MedlinePlus related topics: Kawasaki Disease
U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Defervescence rate within 48 hours after the start of the study drug administration [ Time Frame: Up to 48hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of fever [ Time Frame: Up to Day56 ] [ Designated as safety issue: No ]
  • Incidence of coronary artery lesions [ Time Frame: Day 3, Day 7, Day14, Day 21, Day56 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596335

Contacts
Contact: Clinical Trial Information Desk cti-inq-ml@ml.mt-pharma.co.jp

Locations
Japan
Investigational site Recruiting
Chugoku, Japan
Investigational site Recruiting
Kanto, Japan
Investigational site Recruiting
Kyushu, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Masaaki Mori, MD Yokohama City University Medical Center
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01596335     History of Changes
Other Study ID Numbers: TA-650-22
Study First Received: May 9, 2012
Last Updated: December 20, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Infliximab
REMICADE
TA-650
 intravenous immunoglobulin
Kawasaki disease
IVIG

Additional relevant MeSH terms:
Mucocutaneous Lymph Node Syndrome
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Lymphatic Diseases
Skin Diseases, Vascular
Skin Diseases
 Immunoglobulins
Antibodies
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013