UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000027523
Receipt No. 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 (Ver. 5)

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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
Email 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
Email miyajima@shinshu-u.ac.jp

Sponsor
Institute Shinshu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031499