UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001706
Receipt number 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 15:24:05

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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 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


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

Value
https://center6.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