Clinical Study of TA-650 in Patients With Refractory Kawasaki Disease
Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT01596335
Collaborator
(none)
31
8
2
29
3.9
0.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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).
Study Start Date
:
May 1, 2012
Actual Primary Completion Date
:
Oct 1, 2014
Actual Study Completion Date
:
Oct 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TA-650
|
Drug: 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.
|
| Active Comparator: VGIH
|
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration [Up to 48hours]
Secondary Outcome Measures
- Duration of Fever [Up to Day56]
- Incidence of Coronary Artery Lesions [Day 3, Day 7, Day14, Day 21, Day56]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 10 Years
Sexes Eligible for Study:
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:
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigational site | Chubu | Japan | ||
| 2 | Investigational site | Chugoku | Japan | ||
| 3 | Investigational site | Hokkaido | Japan | ||
| 4 | Investigational site | Kanto | Japan | ||
| 5 | Investigational site | Kyushu | Japan | ||
| 6 | Investigational site | Shinetu | Japan | ||
| 7 | Investigational site | Tohoku | Japan | ||
| 8 | Investigational site | Tokai | Japan |
Sponsors and Collaborators
- Mitsubishi Tanabe Pharma Corporation
Investigators
- Study Director: Masaaki Mori, MD, Yokohama City University Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01596335
Other Study ID Numbers:
- TA-650-22
First Posted:
May 11, 2012
Last Update Posted:
Oct 25, 2018
Last Verified:
Sep 1, 2018
Keywords provided by Mitsubishi Tanabe Pharma Corporation
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
|---|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | Total |
|---|---|---|---|
| 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 Participants | 16 | 15 | 31 |
| Age, Customized (participants) [Number] | |||
| >= 1 and < 2 |
2
12.5%
|
2
13.3%
|
4
12.9%
|
| >= 2 and <= 10 |
14
87.5%
|
13
86.7%
|
27
87.1%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
6
37.5%
|
4
26.7%
|
10
32.3%
|
| Male |
10
62.5%
|
11
73.3%
|
21
67.7%
|
Outcome Measures
| Title | Defervescence Rate Within 48 Hours After the Start of the Study Drug Administration |
|---|---|
| Description | |
| Time Frame | Up to 48hours |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
|---|---|---|
| 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. |
| Measure Participants | 16 | 15 |
| Number [percentage of patients] |
75.0
|
33.3
|
| Title | Duration of Fever |
|---|---|
| Description | |
| Time Frame | Up to Day56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
|---|---|---|
| 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. |
| Measure Participants | 16 | 15 |
| Duration since starting of drug administration |
16.00
|
42.20
|
| Duration since completing of drug administration |
13.90
|
25.90
|
| Title | Incidence of Coronary Artery Lesions |
|---|---|
| Description | |
| Time Frame | Day 3, Day 7, Day14, Day 21, Day56 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis population is evaluation patients. |
| Arm/Group Title | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) |
|---|---|---|
| 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. |
| Measure Participants | 16 | 15 |
| 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
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | ||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/16 (0%) | 1/15 (6.7%) | ||
| Vascular disorders | ||||
| Kawasaki disease | 0/16 (0%) | 1/15 (6.7%) | ||
Other (Not Including Serious) Adverse Events |
||||
| TA-650 | Polyethylene Glycol-treated Human Immunoglobulin (VGIH) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 15/16 (93.8%) | 15/15 (100%) | ||
| Ear and labyrinth disorders | ||||
| Ear pain | 1/16 (6.3%) | 0/15 (0%) | ||
| Gastrointestinal disorders | ||||
| Anal haemorrhage | 0/16 (0%) | 1/15 (6.7%) | ||
| Constipation | 1/16 (6.3%) | 4/15 (26.7%) | ||
| Diarrhoea | 1/16 (6.3%) | 0/15 (0%) | ||
| Stomatitis | 0/16 (0%) | 1/15 (6.7%) | ||
| Vomiting | 1/16 (6.3%) | 2/15 (13.3%) | ||
| General disorders | ||||
| Disuse syndrome | 1/16 (6.3%) | 0/15 (0%) | ||
| Oedema peripheral | 0/16 (0%) | 1/15 (6.7%) | ||
| Pyrexia | 1/16 (6.3%) | 0/15 (0%) | ||
| Infections and infestations | ||||
| Bronchitis | 0/16 (0%) | 2/15 (13.3%) | ||
| Conjunctivitis | 0/16 (0%) | 1/15 (6.7%) | ||
| Fungal skin infection | 0/16 (0%) | 1/15 (6.7%) | ||
| Nasopharyngitis | 3/16 (18.8%) | 2/15 (13.3%) | ||
| Pharyngitis | 0/16 (0%) | 1/15 (6.7%) | ||
| Upper respiratory tract infection | 1/16 (6.3%) | 2/15 (13.3%) | ||
| Injury, poisoning and procedural complications | ||||
| Arthropod sting | 1/16 (6.3%) | 0/15 (0%) | ||
| Contusion | 1/16 (6.3%) | 0/15 (0%) | ||
| Skin injury | 0/16 (0%) | 1/15 (6.7%) | ||
| Investigations | ||||
| Activated partial thromboplastin time prolonged | 0/16 (0%) | 1/15 (6.7%) | ||
| Blood cholesterol increased | 0/16 (0%) | 1/15 (6.7%) | ||
| Double stranded DNA antibody positive | 11/16 (68.8%) | 10/15 (66.7%) | ||
| Eosinophil count increased | 0/16 (0%) | 1/15 (6.7%) | ||
| Liver function test abnormal | 1/16 (6.3%) | 0/15 (0%) | ||
| Transaminases increased | 1/16 (6.3%) | 0/15 (0%) | ||
| White blood cells urine positive | 0/16 (0%) | 1/15 (6.7%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Neck pain | 1/16 (6.3%) | 0/15 (0%) | ||
| Nervous system disorders | ||||
| Neuralgia | 1/16 (6.3%) | 0/15 (0%) | ||
| Renal and urinary disorders | ||||
| Renal tubular disorder | 0/16 (0%) | 1/15 (6.7%) | ||
| Respiratory, thoracic and mediastinal disorders | ||||
| Epistaxis | 3/16 (18.8%) | 4/15 (26.7%) | ||
| Respiratory depression | 0/16 (0%) | 1/15 (6.7%) | ||
| Upper respiratory tract inflammation | 3/16 (18.8%) | 2/15 (13.3%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Decubitus ulcer | 0/16 (0%) | 1/15 (6.7%) | ||
| Dermatitis contact | 1/16 (6.3%) | 3/15 (20%) | ||
| Drug eruption | 0/16 (0%) | 1/15 (6.7%) | ||
| Dry skin | 1/16 (6.3%) | 0/15 (0%) | ||
| Miliaria | 1/16 (6.3%) | 0/15 (0%) | ||
| Rash | 2/16 (12.5%) | 0/15 (0%) | ||
| Skin erosion | 0/16 (0%) | 1/15 (6.7%) | ||
| Urticaria | 1/16 (6.3%) | 0/15 (0%) | ||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Clinical Trials, Information Desk |
|---|---|
| Organization | Mitsubishi Tanabe Pharma Corporation |
| Phone | |
| cti-inq-ml@ml.mt-pharma.co.jp |
Responsible Party:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01596335
Other Study ID Numbers:
- TA-650-22
First Posted:
May 11, 2012
Last Update Posted:
Oct 25, 2018
Last Verified:
Sep 1, 2018