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New hope for kids with stubborn kawasaki disease: drug targets fever and heart risks

NCT ID NCT01596335

Disease control Sponsor: Tanabe Pharma Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a drug called TA-650 in 31 children with Kawasaki disease whose fever did not go away after standard IVIG treatment. The goal was to see if TA-650 could bring down the fever faster and prevent damage to heart arteries compared to another immunoglobulin treatment. The drug was given as a single IV infusion, and researchers also checked how the body processes it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TA-650 (a drug given by IV infusion)
What this could lead to
If it works, this could offer a new treatment option for children with Kawasaki disease who don't respond to standard therapy, potentially reducing fever and preventing heart complications.
What could go wrong
This is a small, completed phase 3 trial with only 31 participants, so results may not apply to all patients. The drug may not be more effective than the control treatment, and side effects are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

31 people

The number who actually took part.

Start date

May 2012

Finished

Oct 2014

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Kawasaki disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kawasaki disease refractory to initial therapy with intravenous immunoglobulin

Contacts and locations

Locations

  • Investigational site

    Chugoku, Japan

  • Investigational site

    Chūbu, Japan

  • Investigational site

    Hokkaido, Japan

  • Investigational site

    Kanto, Japan

  • Investigational site

    Kyushu, Japan

  • Investigational site

    Shinetu, Japan

  • Investigational site

    Tōhoku, Japan

  • Investigational site

    Tōkai, Japan