UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019464 |
|---|---|
| Receipt number | R000022512 |
| Scientific Title | Investigation of antiviral treatment for symptomatic congenital cytomegalovirus infection |
| Date of disclosure of the study information | 2015/10/23 |
| Last modified on | 2019/05/14 18:04:47 |
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Basic information
Public title
Investigation of antiviral treatment for symptomatic congenital cytomegalovirus infection
Acronym
antiviral treatment for congenital CMV infection
Scientific Title
Investigation of antiviral treatment for symptomatic congenital cytomegalovirus infection
Scientific Title:Acronym
antiviral treatment for congenital CMV infection
Region
| Japan |
Condition
Condition
Congenital cytomegalovirus infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To treat patients with congenital cytomegalovirus (CMV)-related sensorineural hearing loss (SNHL) or CMV-related clinical abnormalities other than SNHL
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
auditory brainstem response
Key secondary outcomes
levels of CMV DNA in blood
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
oral VGCV at 32mg/kg/day (b.i.d) for 6 weeks
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
| Not applicable |
Age-upper limit
| 1 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with congenital CMV-related SNHL or CMV-related clinical abnormalities other than SNHL
Key exclusion criteria
< 1 month of age
< 32 weeks gestation
< 1800g
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2974
yoshi-i@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshinori |
| Middle name | |
| Last name | Ito |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2974
Homepage URL
yoshi-i@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aichi-pref
Tel
052-744-2479
narita.yuki@adm.nagoya-u.ac.jp
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
| 2015 | Year | 10 | Month | 23 | 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
Main results already published
Date of protocol fixation
| 2009 | Year | 12 | Month | 16 | Day |
Date of IRB
| 2009 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2009 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2019 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022512
