Unique ID issued by UMIN | UMIN000017337 |
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Receipt number | R000015961 |
Scientific Title | Caspofungin Safety investigation in Gifu Hematology Study Group trial |
Date of disclosure of the study information | 2015/05/01 |
Last modified on | 2016/11/03 09:22:51 |
Caspofungin Safety investigation in Gifu Hematology Study Group trial
GHSG 1401
Caspofungin Safety investigation in Gifu Hematology Study Group trial
GHSG 1401
Japan |
Febrile neutropenia or invasive fungal infection associated with hematological malignancies.
Hematology and clinical oncology | Infectious disease |
Malignancy
NO
The aim of this study is to analyze efficacy and safety of caspofungin for patients with febrile neutropenia or invasive fungal infection associated with hematological malignancies.
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
The efficacy of caspofungin for patients with febrile neutropenia or invasive fungal infection.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
An initial dose of 70 mg by intravenous infusion is given followed by 50 mg intravenous daily. Patients who have moderate liver dysfunction consider 35mg intravenous as maintenance dose instead of 50 mg. Inducers of drug clearance consider 70 mg as maintenance dose instead of 50 mg.
18 | years-old | <= |
Not applicable |
Male and Female
Patients who are over 18 years, give an informed concent to participate in this study and meet at least one of following criteria.
1) Invasive fungal infection.
2) Persistent febrile neutropenia unresponsive to empric antibiotic therapy.
1) An allergy of Caspofungin.
2) Severe liver dysfunction.
3) Pregnant or lactating female
4) Prophylaxis for stem cell transplantation patients.
5) Cryptococcosis or mucormycosis.
6) Any other investigator's opinion
60
1st name | |
Middle name | |
Last name | Hisashi Tsurumi |
Gifu University Graduate School of Medicine
Department of Hematology
1-1 Yanagido, Gifu, Japan
058-230-6308
htsuru@gifu-u.ac.jp
1st name | |
Middle name | |
Last name | Takeshi Hara |
Gifu University Graduate School of Medicine
Department of Hematology
1-1 Yanagido, Gifu, Japan
058-230-6308
haratake@muh.biglobe.ne.jp
Department of Hematology, Gifu University Graduate School of Medicine
Department of Hematology, Gifu University Graduate School of Medicine
Self funding
NO
2015 | Year | 05 | Month | 01 | Day |
Unpublished
Open public recruiting
2014 | Year | 01 | Month | 31 | Day |
2014 | Year | 02 | Month | 01 | Day |
2015 | Year | 04 | Month | 30 | Day |
2016 | Year | 11 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015961
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