UMIN-CTR Clinical Trial

Basic information
Public title	Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy
Acronym	Sivelestat Sodium Hydrate Treatment for severe Kawasaki Disease
Scientific Title	Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy
Scientific Title:Acronym	Sivelestat Sodium Hydrate Treatment for severe Kawasaki Disease
Region	Japan

Condition
Condition	Kawasaki Disease
Classification by specialty	Pediatrics
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We will conduct the present pilot study to evaluate the use of sivelestat sodium hydrate for patients with refractory Kawasaki disease who had shown resistance to initial intravenous immunoglobulin therapy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is incidence of coronary artery abnormalities during the study period, which we identified with two-dimensional echocardiography.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of sivelestat sodium hydrate
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	Not applicable
Age-upper limit	20 years-old >=
Gender	Male and Female
Key inclusion criteria	We diagnosed Kawasaki disease with the Japanese diagnostic guidelines for Kawasaki disease. Eligible participants are those who remained febrile (37.5 degree Celsius or more of an axillary temperature) 36 to 48 hours after beginning of initial IVIG therapy. Patients who become afebrile within 48 hours after beginning of initial IVIG therapy but become febrile again within day 9 of illness are also considered as refractory to initial IVIG therapy and enrolled in this study.
Key exclusion criteria	We excluded patients who become afebrile within 48 hours after beginning of initial IVIG therapy but become febrile again after day 10 of illness, those with concomitant severe medical disorders (eg, immunodeficiency, chromosomal anomalies, congenital heart diseases, metabolic diseases, nephritis, collagen diseases), those with suspected infectious disease, including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella, and influenza, those with allergy to some drugs and substances and those who have already been enrolled in other clinical trials.
Target sample size	45

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Ryota Ebata
Organization	Chiba University Hospital
Division name	Department of Pediatrics
Zip code
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	+81-43-222-7171
Email	eba-ryo@chiba-u.jp

Public contact
1st name of contact person	1st name Middle name Last name Ryota Ebata
Organization	Chiba University Hospital
Division name	Department of Pediatrics
Zip code
Address	1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
TEL	+81-43-222-7171
Homepage URL
Email	eba-ryo@chiba-u.jp

Sponsor
Institute	Department of Pediatrics, Chiba University Hospital
Institute
Department

Funding Source
Organization	Teijin Pharma Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information	2014 Year 02 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
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 12 Month 20 Day
Date of IRB	2006 Year 12 Month 20 Day
Anticipated trial start date	2006 Year 12 Month 20 Day
Last follow-up date	2016 Year 02 Month 14 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 01 Month 30 Day
Last modified on	2019 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015197