UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017337 |
|---|---|
| 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 |
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Basic information
Public title
Caspofungin Safety investigation in Gifu Hematology Study Group trial
Acronym
GHSG 1401
Scientific Title
Caspofungin Safety investigation in Gifu Hematology Study Group trial
Scientific Title:Acronym
GHSG 1401
Region
| Japan |
Condition
Condition
Febrile neutropenia or invasive fungal infection associated with hematological malignancies.
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The efficacy of caspofungin for patients with febrile neutropenia or invasive fungal infection.
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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.
Key exclusion criteria
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
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Tsurumi |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Hematology
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
htsuru@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takeshi Hara |
Organization
Gifu University Graduate School of Medicine
Division name
Department of Hematology
Zip code
Address
1-1 Yanagido, Gifu, Japan
TEL
058-230-6308
Homepage URL
haratake@muh.biglobe.ne.jp
Sponsor or person
Institute
Department of Hematology, Gifu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 05 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 30 | Day |
Last modified on
| 2016 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015961
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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