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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004792
Receipt No. R000005703
Scientific Title Phase II study of pre-emptive therapy for low-level positive cytomegalovirus antigenemia by low-dose valganciclovir after allogeneic hematopoietic stem cell transplantation
Date of disclosure of the study information 2011/01/01
Last modified on 2014/06/30

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Basic information
Public title Phase II study of pre-emptive therapy for low-level positive cytomegalovirus antigenemia by low-dose valganciclovir after allogeneic hematopoietic stem cell transplantation
Acronym Pre-emptive therapy for low-level positive cytomegalovirus antigenemia by low-dose valganciclovir after allogeneic hematopoietic stem cell transplantation
Scientific Title Phase II study of pre-emptive therapy for low-level positive cytomegalovirus antigenemia by low-dose valganciclovir after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym Pre-emptive therapy for low-level positive cytomegalovirus antigenemia by low-dose valganciclovir after allogeneic hematopoietic stem cell transplantation
Region
Japan

Condition
Condition Patients with low-level positive cytomegalovirus antigenemia after allogeneic hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Efficacy of low-dose valganciclovir for low-level positive cytomegalovirus antigenemia after allogeneic hematopoeitic stem cell transplantation
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Efficacy of low-dose valganciclovir for low-level positive cytomegalovirus antigenemia
Key secondary outcomes Safety of low-dose valganciclovir
Incidence of cytomegalovirus-associated disease

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 valganciclovir
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
20 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria After allogeneic hematopoietic stem cell transplantation
Low-level positive cytomegalovirus antigenemia (C7-HRP >=2/50,000WBCs and <10/50,000WBCs)
No cytomegalovirus-associated disease
Patients who can take medicines perorally
Performance status 0-2
No major organ complication
Key exclusion criteria Negative cytomegalovirus antibodies of both of donors and recipients
T-cell depleted or CD34-positive cell selected transplantation
Gut GVHD (>=stage 2)
HLA more than 2 locus disparity
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Akashi
Organization Kyushu University Hospital
Division name Dept of Hematology/Oncology
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5230
Email akashi@intmed1.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Katsuto Takenaka
Organization Kyushu University Hospital
Division name Dept of Hematology/Oncology
Zip code
Address 3-1-1 Maidashi Higashi-ku, Fukuoka 812-8582, Japan
TEL 092-642-5230
Homepage URL
Email takenaka@intmed1.med.kyushu-u.ac.jp

Sponsor
Institute Dept of Hematology/Oncology, Kyushu University Hospital, Fukuoka, Japan
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kurume Unversity Hospital, Fukuoka, Japan
Hamanomachi Hospital, Fukuoka, Japan
Harasanshin Hospital, Fukuoka, Japan
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 九州大学病院(福岡県),久留米大学病院(福岡県),浜の町病院(福岡県),原三信病院(福岡県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 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 Enrolling by invitation
Date of protocol fixation
2009 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2009 Year 12 Month 01 Day
Last follow-up date
2011 Year 06 Month 01 Day
Date of closure to data entry
2011 Year 12 Month 01 Day
Date trial data considered complete
2011 Year 12 Month 01 Day
Date analysis concluded
2011 Year 12 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 12 Month 26 Day
Last modified on
2014 Year 06 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005703

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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