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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001346
Receipt No. 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

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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
Email

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
Email ishiyamak@med3.m.kanazawa-u.ac.jp

Sponsor
Institute Cellular transplantation biology,
Graduate School of Medical Science, Kanazawa University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001633

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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