UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060690 |
|---|---|
| Receipt number | R000066752 |
| Scientific Title | Drug Use-Results Survey of ELEVIDYS for Injection (All-Patient Surveillance) |
| Date of disclosure of the study information | 2026/02/17 |
| Last modified on | 2026/02/17 08:56:27 |
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Basic information
Public title
Drug Use-Results Survey of ELEVIDYS for Injection (All-Patient Surveillance)
Acronym
Drug Use-Results Survey of ELEVIDYS for Injection (All-Patient Surveillance)
Scientific Title
Drug Use-Results Survey of ELEVIDYS for Injection (All-Patient Surveillance)
Scientific Title:Acronym
Drug Use-Results Survey of ELEVIDYS for Injection (All-Patient Surveillance)
Region
| Japan |
Condition
Condition
Duchenne Muscular Dystrophy
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to understand the long-term safety profile (incidence rate, time of onset, outcome, etc.) of this product under real-world usage conditions. Secondarily, long-term efficacy parameters will also be assessed.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of adverse events, event name, onset date, worst Grade, severity, treatment, outcome, outcome date, causality
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients who are scheduled to receive this product until a decision is made on the new approval application within the time limit of conditional and time-limited approval. If a patient receiving this product transfers to another hospital (including cases where they are concurrently examined for Duchenne Muscular Dystrophy (DMD) at another facility) during the observation period, registration should also be conducted at the transfer destination medical institution.
Key exclusion criteria
None
Target sample size
86
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Takemoto |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science 2 Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
takemotosny@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Murayama |
Organization
Chugai Pharmaceutical Co. Ltd.
Division name
Safety science 2 Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
murayamaayk@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co. Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
None
Address
None
Tel
None
None
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
| 2026 | Year | 02 | Month | 17 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 02 | Month | 17 | Day |
Last modified on
| 2026 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066752
