UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001346 |
|---|---|
| Receipt number | R000001633 |
| Scientific Title | Prospective study of Foscarnet sodium administration for the prevention of HHV-6 encephalitis after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2008/08/30 |
| Last modified on | 2009/05/08 15:46:52 |
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Basic information
Public title
Prospective study of Foscarnet sodium administration for the prevention of HHV-6 encephalitis after hematopoietic stem cell transplantation
Acronym
Preemptive therapy with Foscarnet for the prevention of HHV-6 encephalitis
Scientific Title
Prospective study of Foscarnet sodium administration for the prevention of HHV-6 encephalitis after hematopoietic stem cell transplantation
Scientific Title:Acronym
Preemptive therapy with Foscarnet for the prevention of HHV-6 encephalitis
Region
| Japan |
Condition
Condition
Patients with hematologic malignancies, transplanted unrelated cord blood (UCBT) or HLA-one haplotype mismatch graft from a relative (haplo SCT)
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Limbic encephalitis is a complication after UCBT, caused by Human Herpesvirus-6 (HHV-6) with poor prognosis. Ganciclovir (GCV) and Foscarnet (PFA) are known as therapeutic drugs for HHV-6 infection, but no drugs are approved in Japan. PFA is easy-to-use after hematopoietic stem cell transplantation (HSCT), because GCV causes bone marrow suppression as a major side effect. We conduct a prospective study of PFA preemptive therapy after SCT to validate; 1. safety of PFA administration, 2. change of plasma HHV-6 DNA, 3. preventative effect for limbic encephalitis.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Frequency of adverse event caused by PFA administration by day 35 after SCT.
Key secondary outcomes
1. Change of plasma HHV-6 DNA after PFA administration by day 35 after SCT.
2. Preventive effect of PFA administration by day 35 after SCT.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We measure the amount of HHV-6 DNA in plasma triweekly. When the amount of HHV-6 DNA excess 5x10e2 copy/ml, we start PFA administration 90mg/kg/day and continue the measurement triweekly. In case the amount of HHV-6 DNA excess 1x10e5 copy/ml, we increase PFA doses for 180mg/kg/day, and in case HHV-6 DNA become negative, stop PFA administration.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with hematologic disease who are transplanted unrelated cord blood or HLA-haploidentical hematopoietic stem cell from a relative.
Key exclusion criteria
1. Hypersensitive for PFA
2. Existence of comorbid disease, grade 3 or more in CTCAE v3.0 (except renal insufficiency)
3. Existence of renal insufficiency, grade 2 or more in CTCAE v3.0
4. Unsuitable for enrollment judged by attending physian
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NAKAO, Shinji |
Organization
Graduate School of Medical Science,
Kanazawa University
Division name
Cellular transplantation biology
Zip code
Address
13-1, Takaramachi, Kanazawa, Ishikawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | ISHIYAMA, Ken |
Organization
Graduate School of Medical Science, Kanazawa University
Division name
Cellular transplantation biology
Zip code
Address
TEL
Homepage URL
ishiyamak@med3.m.kanazawa-u.ac.jp
Sponsor or person
Institute
Cellular transplantation biology,
Graduate School of Medical Science, Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Study group 'Morishima-han' to establish allo-SCT for refractory hematologic malignancies in adults, Ministry of Health, Labour and welfare.
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2007 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 30 | Day |
Last modified on
| 2009 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001633
