UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001905 |
|---|---|
| Receipt number | R000002316 |
| Scientific Title | Use of micafungin as antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2009/05/01 |
| Last modified on | 2009/04/24 23:22:22 |
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Basic information
Public title
Use of micafungin as antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation.
Acronym
Use of micafungin as antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation.
Scientific Title
Use of micafungin as antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation.
Scientific Title:Acronym
Use of micafungin as antifungal prophylaxis in patients undergoing hematopoietic stem cell transplantation.
Region
| Japan |
Condition
Condition
hematological malignancies
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is the efficacy and tolerance of micafungin as antifungal prophylaxis in neutropenic patients undergoing hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary end point is treatment success, which is defined as the absence of fungal infection through the prophylaxis therapy of micafungin and as the absence of fungal infection through the end of the 4-week posttreatment period.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients receives a 50-mg dose of micafungin once daily as a 1-hour infusion. This prophylaxis is initiated within 24 hours of the beginning of the transplant-related conditioning regimen. Patients receives the prophylaxis until the earliest of the following: < 5 days after engraftment (defined as an absolute neutrophil count of 500 cells/mm3 after the nadir absolute count).
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing hematopoietic stem cell transplantation (Age 16 > years)
Patients do not have received antifungal therapy within 72 hours before adminiatrarion of the first dose of the study drug.
Key exclusion criteria
Patients are free of fungal infection at the time of enrollment.
Patients have a history of a serious allergy to the study drug.
Patients have a serious liver dysfunction.
Patients have received micafungin within 7 days before the time of enrollment.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroki Yokoyama |
Organization
The Jikei university school of medicine
Division name
Division of clinical oncology/hematology department of internal medicine
Zip code
Address
3-25-8 Nishi-Shinbashi, Minato-ku, Tokyo 105-8461 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei university school of medicine
Division name
Division of clinical oncology/hematology department of internal medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
The Jikei university school of medicine
Institute
Department
Personal name
Funding Source
Organization
The Jikei university 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
| 2009 | 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
Preinitiation
Date of protocol fixation
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 24 | Day |
Last modified on
| 2009 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002316
