Kawasaki Disease Refractory to Initial Therapy With Intravenous ImmunoglobulinPhase 3NCT01596335
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
A Phase 3 study testing TA-650 and Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in people with Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin, run by Tanabe Pharma Corporation at 8 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
- What is being tested?
- TA-650 and Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 8 sitesJapan
- Study dates
- May 2012to Oct 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Investigational site
Chūbu
Investigational site
Chugoku
Investigational site
Hokkaido
Investigational site
Kanto
Investigational site
Kyushu
Investigational site
Shinetu
Investigational site
Tōhoku
Investigational site
Tōkai
About this study
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).
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.
- Being tested
- TA-650, Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
- Keywords
- Infliximab, REMICADE, TA-650, intravenous immunoglobulin, Kawasaki disease, IVIG
- Medical subject headings
- Mucocutaneous Lymph Node Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| TA-650 | Experimental | Not described Receives: Drug: TA-650 |
| VGIH | Active comparator | Not described Receives: Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
Measured: Up to 48hours
Secondary outcomes (2)
Duration of Fever
Measured: Up to Day56
Incidence of Coronary Artery Lesions
Measured: Day 3, Day 7, Day14, Day 21, Day56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kawasaki Disease Refractory to Initial Therapy With Intravenous ImmunoglobulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masaaki Mori, MD, Study director, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01596335
- Sponsor's protocol ID
- TA-650-22
- Status last verified
- Dec 2025
- First submitted
- 9 May 2012
- Last updated
- 7 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29386515
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01596335
- Acronym / sponsor ID
- TA-650-22
- Keywords
- Infliximab, REMICADE, TA-650, intravenous immunoglobulin, Kawasaki disease, IVIG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 May 2012 (estimated)
- Results
- Posted 26 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TA-650 | Experimental | Drug: TA-650 |
| VGIH | Active comparator | Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TA-650TA-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. | Drug | TA-650 |
| 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. | Drug | VGIH |
Primary outcome
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
Time frame: Up to 48hours
2 secondary outcomes
Duration of Fever
Time frame: Up to Day56
Incidence of Coronary Artery Lesions
Time frame: Day 3, Day 7, Day14, Day 21, Day56
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29386515Mori 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masaaki Mori, MD study director
Yokohama City University Medical Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TA-650 and Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in people with Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin, run by Tanabe Pharma Corporation at 8 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Sep 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration (time frame: Up to 48hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01596335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.