UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010591 |
|---|---|
| Receipt number | R000012379 |
| Scientific Title | The clinical effects of foscarnet prophylaxis for human herpes virus type 6 associated limbic encephalitis after umbilical cord blood transplantation |
| Date of disclosure of the study information | 2013/04/25 |
| Last modified on | 2014/12/01 21:57:30 |
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Basic information
Public title
The clinical effects of foscarnet prophylaxis for human herpes virus type 6 associated limbic encephalitis after umbilical cord blood transplantation
Acronym
The clinical effects of foscarnet prophylaxis for human herpes virus type 6 associated limbic encephalitis after umbilical cord blood transplantation
Scientific Title
The clinical effects of foscarnet prophylaxis for human herpes virus type 6 associated limbic encephalitis after umbilical cord blood transplantation
Scientific Title:Acronym
The clinical effects of foscarnet prophylaxis for human herpes virus type 6 associated limbic encephalitis after umbilical cord blood transplantation
Region
| Japan |
Condition
Condition
Human herpes virus type 6-associated limbic encephalitis after umbilical cord blood transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will prospectively examine the efficacy of foscarnet prophylaxis for prevention of human herpes virus type 6-associated limbic encephalitis after umbilical cord blood tranplantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of the treatment success defined by the following criteria during the period from transplantation to day 50
Key secondary outcomes
The incidence of human herpes virus type 6-associated limbic encephalitis
The overall survival at 100days after cord blood tranplantation
The rate of incidence of cytomegalovirus infection
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
We administer foscarnet 120mg/kg/day from day 7 to day 50 in cord blood transplant receipient. In case who has pre-engraftment immuno reaction, we increase foscarnet doses for 180mg/kg/day.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
patients with hematopoietic disorders who is going to undergo cord blood transplantation
Key exclusion criteria
1) Hypersensitive for foscarnet
2) Existence of comorbid disease, grade 3 or more in CTCAE v3.0
3) Unsuitable for enrollment judged by attending physian
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Ishiwata |
Organization
Toranomon Hospital
Division name
Department of Hematology
Zip code
Address
Toranomon2-2-2 Minato-ku Tokyo-to
TEL
03-3588-1111
kazboo1979@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Ishiwata |
Organization
Toranomon Hospital
Division name
Departmetn of Hematology
Zip code
Address
Toranomon2-2-2 Minato-ku Tokyo-to
TEL
03-3588-1111
Homepage URL
kazboo1979@gmail.com
Sponsor or person
Institute
Toranomon Hospital
Department of Hematology
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
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
国家公務員共済組合連合会 虎の門病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 25 | 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
| 2013 | Year | 04 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 07 | Month | 25 | Day |
Date analysis concluded
| 2015 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 25 | Day |
Last modified on
| 2014 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012379
