UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052037 |
|---|---|
| Receipt number | R000059360 |
| Scientific Title | Open Label Single-arm, Multicenter Trial for Reducing Ganciclovir / Valganciclovir in Congenital Cytomegalovirus Infection with NUDT 15 R139C mutation |
| Date of disclosure of the study information | 2023/11/01 |
| Last modified on | 2023/08/29 12:17:41 |
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Basic information
Public title
Effectiveness of Ganciclovir / Valganciclovir Dose Optimization by NUDT 15 R139C mutation on Reducing Ganciclovir/Valganciclovir-induced Leucopenia in Congenital Cytomegalovirus Infection
Acronym
Effectiveness of Reducing Ganciclovir / Valganciclovir in Congenital Cytomegalovirus Infection with NUDT 15 R139C mutation
Scientific Title
Open Label Single-arm, Multicenter Trial for Reducing Ganciclovir / Valganciclovir in Congenital Cytomegalovirus Infection with NUDT 15 R139C mutation
Scientific Title:Acronym
OPTIGAN trial
Region
| Japan |
Condition
Condition
Symptomatic Congenital Cytomegalovirus Infection or Acquired cytomegalovirus infection in Preterm Birth Infants
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To Confirm safety and effectiveness for reducing Ganciclovir / Valganciclovir in NUDT 15 R139C mutation cases with side effects in congenital cytomegalovirus infection or acquired cytomegalovirus infection in preterm birth infants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Suppression of Cytomegalovirus titer in blood, Improvement of clinical symptoms, and Side effects are evaluated weekly during therapy.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with NUDT15 R139C heterozygous mutation are administered with 50% dose of ganciclovir/valganciclovir.
Patients with NUDT15 R139C homozygous mutation are administered with 10% dose of ganciclovir/valganciclovir.
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 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with NUDT15 R139C hetero/homozygous mutation.
2. Patients who met the drug withdrawal criteria after normal doses of ganciclovir/valganciclovir.
(Any of the following drug withdrawal criteria: Neutrophil < 500/mm3, Platelet < 50,000/mm3, Hemoglobin < 8g/dL, AST or ALT > 500 IU/mL or more than 10 times the base levels.)
Key exclusion criteria
1. No improvement of symptoms at the time of drug withdrawal.
2. The Inhibitory effect of virus titer cannot be confirmed at the time of drug withdrawal.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Torii |
Organization
Nagoya University Hospital
Division name
Division of pediatrics
Zip code
4668550
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city
TEL
0527442294
yucali@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Torii |
Organization
Nagoya University Hospital
Division name
Division of Pediatrics
Zip code
4668550
Address
65 Tsumai-cho, Showa-ku, Nagoya-city
TEL
0527442294
Homepage URL
yucali@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self Funding
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
The Ethics Committee of Nagoya University
Address
65 Tsurumai-cho, Showa-ku, Nagoya-city
Tel
0527442294
ethics@med.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
| 2023 | Year | 11 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059360
