Unique ID issued by UMIN | UMIN000013018 |
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Receipt number | R000015197 |
Scientific Title | Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy |
Date of disclosure of the study information | 2014/02/01 |
Last modified on | 2019/03/22 11:59:35 |
Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy
Sivelestat Sodium Hydrate Treatment for severe Kawasaki Disease
Sivelestat Sodium Hydrate Treatment for Patients with Kawasaki Disease refractory to initial intravenous immunoglobulin therapy
Sivelestat Sodium Hydrate Treatment for severe Kawasaki Disease
Japan |
Kawasaki Disease
Pediatrics |
Others
NO
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.
Safety,Efficacy
The primary endpoint is incidence of coronary artery abnormalities during the study period, which we identified with two-dimensional echocardiography.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Administration of sivelestat sodium hydrate
Not applicable |
20 | years-old | >= |
Male and Female
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.
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.
45
1st name | |
Middle name | |
Last name | Ryota Ebata |
Chiba University Hospital
Department of Pediatrics
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
+81-43-222-7171
eba-ryo@chiba-u.jp
1st name | |
Middle name | |
Last name | Ryota Ebata |
Chiba University Hospital
Department of Pediatrics
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
+81-43-222-7171
eba-ryo@chiba-u.jp
Department of Pediatrics,
Chiba University Hospital
Teijin Pharma Co., Ltd
Profit organization
NO
2014 | Year | 02 | Month | 01 | Day |
Unpublished
Completed
2006 | Year | 12 | Month | 20 | Day |
2006 | Year | 12 | Month | 20 | Day |
2006 | Year | 12 | Month | 20 | Day |
2016 | Year | 02 | Month | 14 | Day |
2014 | Year | 01 | Month | 30 | Day |
2019 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015197
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