Trial · NCT01596335

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

NCT01596335, Phase 3, Completed, Tanabe Pharma Corporation; results first posted 2018-09-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease. Trials, record NCT01596335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01596335

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
NCT number: NCT01596335
Status: Completed
Phases: Phase 3
Enrollment: 31 participants, actual
Lead sponsor: Tanabe Pharma Corporation
Conditions: Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Interventions: TA-650, Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
First posted: 2012-05-11
Last updated: 2026-01-07
Results first posted: 2018-09-26

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
Primary	Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration	Up to 48hours
Secondary	Duration of Fever	Up to Day56
Secondary	Incidence of Coronary Artery Lesions	Day 3, Day 7, Day14, Day 21, Day56

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration	Up to 48hours		percentage of patients	NUMBER
SECONDARY	Duration of Fever	Up to Day56		hour	MEDIAN
SECONDARY	Incidence of Coronary Artery Lesions	Day 3, Day 7, Day14, Day 21, Day56	The analysis population is evaluation patients.	percentage of patients	NUMBER

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration	TA-650		75.0		percentage of patients
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)		33.3		percentage of patients
Duration of Fever	TA-650	Duration since starting of drug administration	16.00	Inter-Quartile Range 7.70 to 38.75	hour
Duration of Fever	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Duration since starting of drug administration	42.20	Inter-Quartile Range 20.00 to 60.70	hour
Duration of Fever	TA-650	Duration since completing of drug administration	13.90	Inter-Quartile Range 5.90 to 36.50	hour
Duration of Fever	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Duration since completing of drug administration	25.90	Inter-Quartile Range 17.30 to 39.80	hour
Incidence of Coronary Artery Lesions	TA-650	Day 3	0		percentage of patients
Incidence of Coronary Artery Lesions	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Day 3	12.5		percentage of patients
Incidence of Coronary Artery Lesions	TA-650	Day 7	0		percentage of patients
Incidence of Coronary Artery Lesions	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	Day 7	14.3		percentage of patients

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	TA-650	16
Overall Study	STARTED	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	15
Overall Study	COMPLETED	TA-650	11
Overall Study	COMPLETED	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	6
Overall Study	NOT COMPLETED	TA-650	5
Overall Study	NOT COMPLETED	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	9

Source ClinicalTrials.gov

Adverse events80

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Bronchitis	Infections and infestations	TA-650	0	16
other	Bronchitis	Infections and infestations	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	2	15
other	Conjunctivitis	Infections and infestations	TA-650	0	16
other	Conjunctivitis	Infections and infestations	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	1	15
other	Fungal skin infection	Infections and infestations	TA-650	0	16
other	Fungal skin infection	Infections and infestations	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	1	15
other	Nasopharyngitis	Infections and infestations	TA-650	3	16
other	Nasopharyngitis	Infections and infestations	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	2	15
other	Pharyngitis	Infections and infestations	TA-650	0	16
other	Pharyngitis	Infections and infestations	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	1	15

1 to 10 of 80Source ClinicalTrials.gov

See all 80 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	TA-650
Total, all-cause mortality	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Total, other adverse events	TA-650	15	16
Total, other adverse events	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	15	15
Total, serious adverse events	TA-650	0	16
Total, serious adverse events	Polyethylene Glycol-treated Human Immunoglobulin (VGIH)	1	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
29386515	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
TA-650 vs Polyethylene Glycol-treated Human Immunoglobulin (VGIH): serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01596335

GET https://conductscience.org/api/trials/v1/NCT01596335/events?page=2

API reference For AI assistants