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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024078
Receipt No. R000027724
Scientific Title The use of Foscavir for ganciclovir-resistant Cytomegaro virus infection
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/16

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Basic information
Public title The use of Foscavir for ganciclovir-resistant Cytomegaro virus infection
Acronym The use of Foscavir for CMV
Scientific Title The use of Foscavir for ganciclovir-resistant Cytomegaro virus infection
Scientific Title:Acronym The use of Foscavir for CMV
Region
Japan

Condition
Condition gancivlovir-resistant CMV infection
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 lifesaving for pacient
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of the cytomegalovirus antigenemia test
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
53 years-old <=
Age-upper limit
60 years-old >=
Gender Female
Key inclusion criteria ganciclovir-resistant CMV infection
Key exclusion criteria none
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Ihn
Organization Kumamoto University medical school
Division name Department of Dermatology
Zip code
Address 1-1-1 honjo Kumamotocity
TEL 0963442111
Email gogohautouto@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiko Nagamoto
Organization Kumamoto University medical school
Division name Department of Dermatology
Zip code
Address 1-1-1 honjo Kumamotocity
TEL 0963442111
Homepage URL
Email gogohautouto@yahoo.co.jp

Sponsor
Institute Department of dermatology Kumamoto University medical school
Institute
Department

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
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
2016 Year 10 Month 01 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
2016 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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 none

Management information
Registered date
2016 Year 09 Month 16 Day
Last modified on
2016 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027724

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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