UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001706
Receipt No. R000002061
Scientific Title Prospective study of preventive Foscarnet sodium administration to confirm the safety and preventive effect of HHV-6 encephalitis after hematopoietic stem cell transplantation
Date of disclosure of the study information 2009/02/13
Last modified on 2010/04/27

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study of preventive Foscarnet sodium administration to confirm the safety and preventive effect of HHV-6 encephalitis after hematopoietic stem cell transplantation
Acronym Preventive therapy using Foscarnet for the HHV-6 infection after hematopoietic stem cell transplantation
Scientific Title Prospective study of preventive Foscarnet sodium administration to confirm the safety and preventive effect of HHV-6 encephalitis after hematopoietic stem cell transplantation
Scientific Title:Acronym Preventive therapy using Foscarnet for the HHV-6 infection after hematopoietic stem cell transplantation
Region
Japan

Condition
Condition Hematologic disorder, who receive hematopoietic stem cell transplantation (HSCT) from alternative donor
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We prospectively examine the safety of PFA administration, preventive effect of Human herpesvirus-6 (HHV-6) and cytomegalovirus (CMV), and graft-versus-host disease after HSCT.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety of PFA administration at early post-HSCT period
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 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 PFA 90mg/kg/day from day +7 to day +21 in bone marrow transplant/peripheral blood stem cell transplant receipient and to day +25 in cord blood transplant receipient. During the PFA adminstration, we measure the amount of plasma HHV-6 triweekly. In case the amount of HHV-6 DNA excess 1x10e4 copy/ml, we increase PFA 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
16 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Patients with hematologic disease who are transplanted from alternative donor.
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 ISHIYAMA, Ken
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
2009 Year 02 Month 13 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
2009 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2010 Year 03 Month 01 Day
Date of closure to data entry
2010 Year 03 Month 01 Day
Date trial data considered complete
2010 Year 05 Month 01 Day
Date analysis concluded
2010 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 02 Month 13 Day
Last modified on
2010 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.