UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000348 |
|---|---|
| Receipt number | R000000445 |
| Scientific Title | Prevention of VZV reactivation using long-term low-dose valacyclovir after allogeneic hematopoietic stem cell transplantation. |
| Date of disclosure of the study information | 2006/03/10 |
| Last modified on | 2007/09/13 12:26:32 |
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Basic information
Public title
Prevention of VZV reactivation using long-term low-dose valacyclovir after allogeneic hematopoietic stem cell transplantation.
Acronym
Prevention of VZV reactivation using long-term low-dose VCV.
Scientific Title
Prevention of VZV reactivation using long-term low-dose valacyclovir after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym
Prevention of VZV reactivation using long-term low-dose VCV.
Region
| Japan |
Condition
Condition
allogeneic hematopoietic stem cell transplantation recipients
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of long-term low-dose valacyclovir on the incidence of VZV reactivation after allogeneic hematopoietic stem cell transplantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Incidence of VZV reactivation within 2 years after transplantation.
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Start valacyclovir at 500mg/day thrice weekly from day 36 after transplantation.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
allogeneic hematopoietic stem cell transplantation recipients
Key exclusion criteria
Patients with hematological malignancies not in remission.
Severe organ dysfunction
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
University of Tokyo Hospital
Division name
Department of Hematology & Oncology
Zip code
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3815-5411
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Kanda |
Organization
University of Tokyo Hospital
Division name
Department of Hematology & Oncology
Zip code
Address
7-3-1 Hongo, Bunkyo, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
ycanda-tky@umin.ac.jp
Sponsor or person
Institute
Japan Hematology & Oncology Clinical Study Group (J-HOCS)
Institute
Department
Personal name
Funding Source
Organization
Japan Hematology & Oncology Clinical Study Group (J-HOCS)
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2006 | Year | 03 | Month | 10 | 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
Completed
Date of protocol fixation
| 2002 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 03 | Day |
Last modified on
| 2007 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000445
