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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000010591
Receipt No. 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

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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
Email 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
Email kazboo1979@gmail.com

Sponsor
Institute Toranomon Hospital
Department of Hematology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012379

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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