UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027523 |
|---|---|
| Receipt number | R000031499 |
| Scientific Title | Noncontrolled open-label exploratory clinical trial of additional infliximab therapy for patients with refractory Kawasaki disease who are refractory to intravenous immunoglobulin therapy, additional intravenous immunoglobulin therapy and first infliximab therapy. |
| Date of disclosure of the study information | 2017/06/01 |
| Last modified on | 2020/05/31 19:24:19 |
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Basic information
Public title
Noncontrolled open-label exploratory clinical trial of additional infliximab therapy for patients with refractory Kawasaki disease who are refractory to intravenous immunoglobulin therapy, additional intravenous immunoglobulin therapy and first infliximab therapy.
Acronym
Noncontrolled open-label exploratory clinical trial of additional infliximab therapy for patients with refractory Kawasaki disease who are refractory to intravenous immunoglobulin therapy, additional intravenous immunoglobulin therapy and first infliximab therapy.
Scientific Title
Noncontrolled open-label exploratory clinical trial of additional infliximab therapy for patients with refractory Kawasaki disease who are refractory to intravenous immunoglobulin therapy, additional intravenous immunoglobulin therapy and first infliximab therapy.
Scientific Title:Acronym
Noncontrolled open-label exploratory clinical trial of additional infliximab therapy for patients with refractory Kawasaki disease who are refractory to intravenous immunoglobulin therapy, additional intravenous immunoglobulin therapy and first infliximab therapy.
Region
| Japan |
Condition
Condition
Kawasaki disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the safety and efficacy of additional infliximab therapy in Kawasaki disease patients who are refractory to intravenous immunoglobulin therapy and additional intravenous immunoglobulin therapy and refractory to initial infliximab therapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of fever exceeding 37.5 degrees Celsius
Key secondary outcomes
Presence or absence of coronary artery lesion, safety of infliximab administration, and presence or absence of infection during 3 months after administration.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Infliximab is administered intravenously in 2 hours as a dose of 5 mg per kg of body weight.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Kawasaki disease patient who is refractory to intravenous immunoglobulin therapy and additional intravenous immunoglobulin therapy and refractory to initial infliximab therapy
Key exclusion criteria
1. Example which was ineligible for the first infliximab administration
2. Patients with severe infectious complications or sepsis
3. Patients with a history of demyelinating disease
4. Patients with a history of malignant tumors
5. Patients with a history of tuberculosis infection or tuberculosis
6. Patients with less than 6 months after BCG vaccination
7. Patients with less than 1 month after live vaccination
8. Patients who showed allergy symptoms in the first infliximab administration
9. Patients with congestive heart failure
10. Patients who are receiving steroids or other immunosuppressants
11. In addition, patients whose research managers judged inappropriate as subjects
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Hachiya |
Organization
Shinshu University School of Medicine
Division name
Pediatrics
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2642
ahachi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuuka |
| Middle name | |
| Last name | Miyajima |
Organization
Shinshu University School of Medicine
Division name
Pediatrics
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2642
Homepage URL
miyajima@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Shinshu University School of Medicine, department of pediatrics
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2642
ahachi@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
5
Results
Additional infliximab was administered to 5 patients with refractory Kawasaki disease. Fever was resolved in 2 cases and it was judged that there was an effect. The other 3 cases were judged to be refractory due to fever persistence and additional treatment was performed.
Results date posted
| 2020 | Year | 05 | Month | 31 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Although the primary evaluation items have been evaluated, they have not been considered.
Date of the first journal publication of results
Baseline Characteristics
This study was aimed at patients with refractory Kawasaki disease who received high-dose intravenous immunoglobulin therapy twice and infliximab once and exhibited persistent fever(>37.5 degrees).
Participant flow
After receiving a sufficient explanation for participation in this study, the subjects were patients who gave written consent based on the free will of the patient or his / her representative.
Adverse events
none
Outcome measures
After administration of infliximab, the presence or absence of fever above 37.5 degrees was the primary endpoint.
Secondary endpoints were the presence or absence of coronary artery disease, the safety of infliximab administration, and the presence of infectious disease.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 19 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 29 | Day |
Last modified on
| 2020 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031499
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