UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004792 |
|---|---|
| Receipt number | 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 10:00:09 |
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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
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
takenaka@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Dept of Hematology/Oncology, Kyushu University Hospital, Fukuoka, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005703
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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