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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000001905
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Jikei university school of medicine
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002316

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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