UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003041 |
|---|---|
| Receipt number | R000003685 |
| Scientific Title | An exploratory study of administration of foscarnet for cytomegalovirus infection and human herpes virus type 6 infection after hematopoietic stem cell transplantation.. |
| Date of disclosure of the study information | 2010/01/20 |
| Last modified on | 2015/03/23 15:55:55 |
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Basic information
Public title
An exploratory study of administration of foscarnet for cytomegalovirus infection and human herpes virus type 6 infection after hematopoietic stem cell transplantation..
Acronym
Foscarnet for CMV and HHV6 infection after HSCT.
Scientific Title
An exploratory study of administration of foscarnet for cytomegalovirus infection and human herpes virus type 6 infection after hematopoietic stem cell transplantation..
Scientific Title:Acronym
Foscarnet for CMV and HHV6 infection after HSCT.
Region
| Japan |
Condition
Condition
Cytomegalovirus infection and human herpes virus type 6 infection after hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety of foscarnet for cytomegalovirus infection and human herpes virus type 6 infection after hematopoietic stem cell transplantation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in viral load at the end of treatment.
Key secondary outcomes
Changes in the symptoms of viral infection at the end of treatment.
Survival at two months after the end of treatment.
Re-administration of antiviral drugs within two months after the end of treatment.
Adverse events.
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
Intravenous administration of foscarnet.
Induction: 90mg/kg, twice a day.
Maintenance: 90mg/kg, once a 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have received hematopoietic stem cell transplantation
2. Patients with cytomegalovirus infection or human herpes virus type 6 infection.
Key exclusion criteria
1. Allergy to foscarnet.
2. The creatinine clearance is less than 0.4mL/min/kg.
3. HIV-positive patients.
4. A woman during pregnancy or potential pregnancy.
5. Patients who are recognized as inadaptable for this trial.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Go Yamamoto |
Organization
University of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo Hospital
Division name
Hematology and Oncology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
University of Tokyo Hospital,
Depaartment of Hematology and Oncology
Institute
Department
Personal name
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
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
| 2010 | Year | 01 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 15 | Day |
Last modified on
| 2015 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003685
