CompletedNCT01596335Updated Jan 7, 2026Results posted

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

A Phase 3 interventional study of TA-650 and Polyethylene Glycol-treated Human Immunoglobulin (VGIH) in Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin, sponsored by Tanabe Pharma Corporation. Completed at 8 sites in Japan. Open to participants aged 1 Year to 10 Years. Per ClinicalTrials.gov, last updated 2026-01-07.

Sponsored by Tanabe Pharma Corporation · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 31
Allocation: Randomized
Ages: 1 Year to 10 Years
Sex: All

Study 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.

Conditions studied

Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin

Browse trials for

Mucocutaneous Lymph Node Syndrome 64

Keywords

Infliximab
REMICADE
TA-650
intravenous immunoglobulin
Kawasaki disease
IVIG

In context

Mucocutaneous Lymph Node Syndrome

64 studies on the registry are indexed under Mucocutaneous Lymph Node Syndrome; 18 are open to participants now.

This study's enrollment of 31 is below the median of 45 across 35 interventional studies indexed under Mucocutaneous Lymph Node Syndrome.

Browse Mucocutaneous Lymph Node Syndrome studies →

Lead sponsor

Tanabe Pharma Corporation is the lead sponsor of 91 studies on the registry; 1 is open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Year to 10 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 31 participants (actual)

Study arms

Experimental
TA-650
Drug: TA-650
Active comparator
VGIH
Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)

Interventions

DrugTA-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.
DrugPolyethylene 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.

What researchers measure

Primary outcomes

Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
Time frame: Up to 48hours

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

Posted Sep 26, 2018

Participant flow

Participant flow — Overall Study
Milestone	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Started	16	15
Completed	11	6
Not completed	5	9
Withdrew: Exacerbation of primary disease	5	9

Outcome measures

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

Time frame:: Up to 48hours
Reported as:: Number · percentage of patients

Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
percentage of patients	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration	75.0	33.3

SecondaryDuration of Fever

Time frame:: Up to Day56
Reported as:: Median · hour

Duration of Fever
hour	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Duration since starting of drug administration	16.00 (7.70 to 38.75)	42.20 (20.00 to 60.70)
Duration since completing of drug administration	13.90 (5.90 to 36.50)	25.90 (17.30 to 39.80)

SecondaryIncidence of Coronary Artery Lesions

Time frame:: Day 3, Day 7, Day14, Day 21, Day56
Reported as:: Number · percentage of patients

Incidence of Coronary Artery Lesions
percentage of patients	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Day 3	0	12.5
Day 7	0	14.3
Day14	0	16.7
Day 21	0	20.0
Day56	0	0.0

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
TA-650	—	0/16 (0%)	15/16 (93.8%)
Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	—	1/15 (6.7%)	15/15 (100%)

Most frequent serious events

Most frequent serious events
Event	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Kawasaki diseaseVascular disorders	0/16	1/15

Most frequent other events

Showing 10 of 39

Most frequent other events
Event	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Double stranded DNA antibody positiveInvestigations	11/16	10/15
EpistaxisRespiratory, thoracic and mediastinal disorders	3/16	4/15
ConstipationGastrointestinal disorders	1/16	4/15
Dermatitis contactSkin and subcutaneous tissue disorders	1/16	3/15
NasopharyngitisInfections and infestations	3/16	2/15
Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders	3/16	2/15
BronchitisInfections and infestations	0/16	2/15
Upper respiratory tract infectionInfections and infestations	1/16	2/15
VomitingGastrointestinal disorders	1/16	2/15
RashSkin and subcutaneous tissue disorders	2/16	0/15

Baseline characteristics

Age, Customized
Age, Customized(participants)	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Total
>= 1 and < 2	2	2	4
>= 2 and <= 10	14	13	27

Sex: Female, Male
Sex: Female, Male(Participants)	TA-650	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Total
Female	6	4	10
Male	10	11	21

Study locations

8 sites

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

References and documents

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 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jan 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01596335
Lead sponsor: Tanabe Pharma Corporation
Responsible party: Sponsor
First posted: May 11, 2012
Start date: May 2012
Primary completion: Oct 2014
Completion: Oct 2014
Results posted: Sep 26, 2018
Last update: Jan 7, 2026

Study contacts

Masaaki Mori, MD

study director · Yokohama City University Medical Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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