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

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ClinicalTrials.gov Identifier: NCT01596335
Recruitment Status : Completed
First Posted : May 11, 2012
Results First Posted : September 26, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kawasaki Disease Refractory to Initial Therapy With Intravenous Immunoglobulin
Interventions Drug: TA-650
Drug: Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Hide Arm/Group Description 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) 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.
Period Title: Overall Study
Started 16 15
Completed 11 6
Not Completed 5 9
Reason Not Completed
exacerbation of primary disease             5             9
Arm/Group Title TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH) Total
Hide Arm/Group Description 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) 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 of all reporting groups
Overall Number of Baseline Participants 16 15 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
>= 1 and < 2 2 2 4
>= 2 and <= 10 14 13 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 16 participants 15 participants 31 participants
Female
6
  37.5%
4
  26.7%
10
  32.3%
Male
10
  62.5%
11
  73.3%
21
  67.7%
1.Primary Outcome
Title Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration
Hide Description [Not Specified]
Time Frame Up to 48hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Hide Arm/Group Description:
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) 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 Number of Participants Analyzed 16 15
Measure Type: Number
Unit of Measure: percentage of patients
75.0 33.3
2.Secondary Outcome
Title Duration of Fever
Hide Description [Not Specified]
Time Frame Up to Day56
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Hide Arm/Group Description:
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) 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 Number of Participants Analyzed 16 15
Median (Inter-Quartile Range)
Unit of Measure: hour
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)
3.Secondary Outcome
Title Incidence of Coronary Artery Lesions
Hide Description [Not Specified]
Time Frame Day 3, Day 7, Day14, Day 21, Day56
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population is evaluation patients.
Arm/Group Title TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Hide Arm/Group Description:
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) 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 Number of Participants Analyzed 16 15
Measure Type: Number
Unit of Measure: percentage of patients
Day 3 Number Analyzed 13 participants 8 participants
0 12.5
Day 7 Number Analyzed 13 participants 7 participants
0 14.3
Day14 Number Analyzed 12 participants 6 participants
0 16.7
Day 21 Number Analyzed 11 participants 5 participants
0 20
Day56 Number Analyzed 11 participants 6 participants
0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Hide Arm/Group Description 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) 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.
All-Cause Mortality
TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   1/15 (6.67%) 
Vascular disorders     
Kawasaki disease  0/16 (0.00%)  1/15 (6.67%) 
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TA-650 Polyethylene Glycol-treated Human Immunoglobulin (VGIH)
Affected / at Risk (%) Affected / at Risk (%)
Total   15/16 (93.75%)   15/15 (100.00%) 
Ear and labyrinth disorders     
Ear pain  1/16 (6.25%)  0/15 (0.00%) 
Gastrointestinal disorders     
Anal haemorrhage  0/16 (0.00%)  1/15 (6.67%) 
Constipation  1/16 (6.25%)  4/15 (26.67%) 
Diarrhoea  1/16 (6.25%)  0/15 (0.00%) 
Stomatitis  0/16 (0.00%)  1/15 (6.67%) 
Vomiting  1/16 (6.25%)  2/15 (13.33%) 
General disorders     
Disuse syndrome  1/16 (6.25%)  0/15 (0.00%) 
Oedema peripheral  0/16 (0.00%)  1/15 (6.67%) 
Pyrexia  1/16 (6.25%)  0/15 (0.00%) 
Infections and infestations     
Bronchitis  0/16 (0.00%)  2/15 (13.33%) 
Conjunctivitis  0/16 (0.00%)  1/15 (6.67%) 
Fungal skin infection  0/16 (0.00%)  1/15 (6.67%) 
Nasopharyngitis  3/16 (18.75%)  2/15 (13.33%) 
Pharyngitis  0/16 (0.00%)  1/15 (6.67%) 
Upper respiratory tract infection  1/16 (6.25%)  2/15 (13.33%) 
Injury, poisoning and procedural complications     
Arthropod sting  1/16 (6.25%)  0/15 (0.00%) 
Contusion  1/16 (6.25%)  0/15 (0.00%) 
Skin injury  0/16 (0.00%)  1/15 (6.67%) 
Investigations     
Activated partial thromboplastin time prolonged  0/16 (0.00%)  1/15 (6.67%) 
Blood cholesterol increased  0/16 (0.00%)  1/15 (6.67%) 
Double stranded DNA antibody positive  11/16 (68.75%)  10/15 (66.67%) 
Eosinophil count increased  0/16 (0.00%)  1/15 (6.67%) 
Liver function test abnormal  1/16 (6.25%)  0/15 (0.00%) 
Transaminases increased  1/16 (6.25%)  0/15 (0.00%) 
White blood cells urine positive  0/16 (0.00%)  1/15 (6.67%) 
Musculoskeletal and connective tissue disorders     
Neck pain  1/16 (6.25%)  0/15 (0.00%) 
Nervous system disorders     
Neuralgia  1/16 (6.25%)  0/15 (0.00%) 
Renal and urinary disorders     
Renal tubular disorder  0/16 (0.00%)  1/15 (6.67%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis  3/16 (18.75%)  4/15 (26.67%) 
Respiratory depression  0/16 (0.00%)  1/15 (6.67%) 
Upper respiratory tract inflammation  3/16 (18.75%)  2/15 (13.33%) 
Skin and subcutaneous tissue disorders     
Decubitus ulcer  0/16 (0.00%)  1/15 (6.67%) 
Dermatitis contact  1/16 (6.25%)  3/15 (20.00%) 
Drug eruption  0/16 (0.00%)  1/15 (6.67%) 
Dry skin  1/16 (6.25%)  0/15 (0.00%) 
Miliaria  1/16 (6.25%)  0/15 (0.00%) 
Rash  2/16 (12.50%)  0/15 (0.00%) 
Skin erosion  0/16 (0.00%)  1/15 (6.67%) 
Urticaria  1/16 (6.25%)  0/15 (0.00%) 
1
Term from vocabulary, MedDRA 17.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Name/Title: Clinical Trials, Information Desk
Organization: Mitsubishi Tanabe Pharma Corporation
Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01596335     History of Changes
Other Study ID Numbers: TA-650-22
First Submitted: May 9, 2012
First Posted: May 11, 2012
Results First Submitted: January 23, 2018
Results First Posted: September 26, 2018
Last Update Posted: October 25, 2018