Trial Outcomes & Findings for Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease (NCT NCT01596335)
NCT ID: NCT01596335
Last Updated: 2026-01-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
31 participants
Primary outcome timeframe
Up to 48hours
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
TA-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.
|
Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
|
Overall Study
COMPLETED
|
11
|
6
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
| Measure |
TA-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.
|
Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Overall Study
exacerbation of primary disease
|
5
|
9
|
Baseline Characteristics
Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Baseline characteristics by cohort
| Measure |
TA-650
n=16 Participants
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)
n=15 Participants
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>= 1 and < 2
|
2 participants
n=37 Participants
|
2 participants
n=56 Participants
|
4 participants
n=95 Participants
|
|
Age, Customized
>= 2 and <= 10
|
14 participants
n=37 Participants
|
13 participants
n=56 Participants
|
27 participants
n=95 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=37 Participants
|
4 Participants
n=56 Participants
|
10 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=37 Participants
|
11 Participants
n=56 Participants
|
21 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: Up to 48hoursOutcome measures
| Measure |
TA-650
n=16 Participants
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)
n=15 Participants
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
|
75.0 percentage of patients
|
33.3 percentage of patients
|
SECONDARY outcome
Timeframe: Up to Day56Outcome measures
| Measure |
TA-650
n=16 Participants
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)
n=15 Participants
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Duration of Fever
Duration since starting of drug administration
|
16.00 hour
Interval 7.7 to 38.75
|
42.20 hour
Interval 20.0 to 60.7
|
|
Duration of Fever
Duration since completing of drug administration
|
13.90 hour
Interval 5.9 to 36.5
|
25.90 hour
Interval 17.3 to 39.8
|
SECONDARY outcome
Timeframe: Day 3, Day 7, Day14, Day 21, Day56Population: The analysis population is evaluation patients.
Outcome measures
| Measure |
TA-650
n=16 Participants
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)
n=15 Participants
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Incidence of Coronary Artery Lesions
Day 3
|
0 percentage of patients
|
12.5 percentage of patients
|
|
Incidence of Coronary Artery Lesions
Day 7
|
0 percentage of patients
|
14.3 percentage of patients
|
|
Incidence of Coronary Artery Lesions
Day14
|
0 percentage of patients
|
16.7 percentage of patients
|
|
Incidence of Coronary Artery Lesions
Day 21
|
0 percentage of patients
|
20.0 percentage of patients
|
|
Incidence of Coronary Artery Lesions
Day56
|
0 percentage of patients
|
0.0 percentage of patients
|
Adverse Events
TA-650
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-650
n=16 participants at risk
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)
n=15 participants at risk
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Vascular disorders
Kawasaki disease
|
0.00%
0/16
|
6.7%
1/15
|
Other adverse events
| Measure |
TA-650
n=16 participants at risk
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)
n=15 participants at risk
Polyethylene Glycol-treated Human Immunoglobulin (VGIH) at 2g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/16
|
13.3%
2/15
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
3/16
|
13.3%
2/15
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
1/16
|
13.3%
2/15
|
|
Nervous system disorders
Neuralgia
|
6.2%
1/16
|
0.00%
0/15
|
|
Ear and labyrinth disorders
Ear pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
18.8%
3/16
|
26.7%
4/15
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/16
|
6.7%
1/15
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
18.8%
3/16
|
13.3%
2/15
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Constipation
|
6.2%
1/16
|
26.7%
4/15
|
|
Gastrointestinal disorders
Diarrhoea
|
6.2%
1/16
|
0.00%
0/15
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/16
|
6.7%
1/15
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16
|
13.3%
2/15
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.2%
1/16
|
20.0%
3/15
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
6.2%
1/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.5%
2/16
|
0.00%
0/15
|
|
Skin and subcutaneous tissue disorders
Skin erosion
|
0.00%
0/16
|
6.7%
1/15
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
1/16
|
0.00%
0/15
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.2%
1/16
|
0.00%
0/15
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Disuse syndrome
|
6.2%
1/16
|
0.00%
0/15
|
|
General disorders
Oedema peripheral
|
0.00%
0/16
|
6.7%
1/15
|
|
General disorders
Pyrexia
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Double stranded DNA antibody positive
|
68.8%
11/16
|
66.7%
10/15
|
|
Investigations
Eosinophil count increased
|
0.00%
0/16
|
6.7%
1/15
|
|
Investigations
Liver function test abnormal
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
Transaminases increased
|
6.2%
1/16
|
0.00%
0/15
|
|
Investigations
White blood cells urine positive
|
0.00%
0/16
|
6.7%
1/15
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
1/16
|
0.00%
0/15
|
|
Injury, poisoning and procedural complications
Skin injury
|
0.00%
0/16
|
6.7%
1/15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER