UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013512 |
|---|---|
| Receipt number | R000015787 |
| Scientific Title | Replacement therapy of mitochondrial respiratory chain complex disorders |
| Date of disclosure of the study information | 2014/03/30 |
| Last modified on | 2020/04/07 15:16:47 |
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Basic information
Public title
Replacement therapy of mitochondrial respiratory chain complex disorders
Acronym
Treatment of mitochondrial diseases
Scientific Title
Replacement therapy of mitochondrial respiratory chain complex disorders
Scientific Title:Acronym
Treatment of mitochondrial diseases
Region
| Japan |
Condition
Condition
mitochondrial diseases
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
beneficial change of mitochondrial respiratory chain complex disorders
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
check if replacement therapy is enabled
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
sodium succinate
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
| 1 | years-old | <= |
Age-upper limit
| 5 | years-old | >= |
Gender
Female
Key inclusion criteria
Diagnosed with mitochondrial disease
Key exclusion criteria
none
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | jun |
| Middle name | |
| Last name | Murakami |
Organization
Tottori University Hospital
Division name
pediatrics
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago City
TEL
0859-38-6557
jmurakami-ttr@umin.net
Public contact
Name of contact person
| 1st name | jun |
| Middle name | |
| Last name | Murakami |
Organization
Tottori University Hospital
Division name
pediatrics
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago City
TEL
0859-38-6557
Homepage URL
jmurakami-ttr@umin.net
Sponsor or person
Institute
Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tottori University Hospital
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
Tottori University Ethical Review Board Japan
Address
36-1, Nishi-cho, Yonago City
Tel
0859-38-7014
me-kenkyu@adm.tottori-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
| 2014 | Year | 03 | Month | 30 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2019 | 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
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015787
