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NCT Number: NCT01596335

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

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.

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Key information

Conditions

Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin Cardiovascular Diseases Hemic and Lymphatic Diseases Lymphatic Diseases Mucocutaneous Lymph Node Syndrome Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational site, Chugoku, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TA-650

Drug

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.

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.

Primary outcomes

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

    Time frame: Up to 48hours

Secondary outcomes

  1. Duration of Fever

    Time frame: Up to Day56

  2. Incidence of Coronary Artery Lesions

    Time frame: Day 3, Day 7, Day14, Day 21, Day56

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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).

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 11, 2012
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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