UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036860 |
|---|---|
| Receipt number | R000042003 |
| Scientific Title | Molecular and Pathophigiological analysis of NBAS mutations detected in a case of fever-triggered recurrent acute liver failure |
| Date of disclosure of the study information | 2019/06/01 |
| Last modified on | 2022/11/28 09:52:20 |
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Basic information
Public title
Molecular and Pathophigiological analysis of NBAS mutations detected in a case of fever-triggered recurrent acute liver failure
Acronym
Molecular and Pathophigiological analysis of NBAS mutations detected in a case of fever-triggered recurrent acute liver failure
Scientific Title
Molecular and Pathophigiological analysis of NBAS mutations detected in a case of fever-triggered recurrent acute liver failure
Scientific Title:Acronym
Molecular and Pathophigiological analysis of NBAS mutations detected in a case of fever-triggered recurrent acute liver failure
Region
| Japan |
Condition
Condition
NBAS mutation based disease
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Genetic analyses of NBAS gene in a family with fever-triggered recurrent acute liver failure
Basic objectives2
Others
Basic objectives -Others
Genetic analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of NBAS gene mutation and pathogenesis of mutant NBAS protein
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Genetic analyses of NBAS gene in a family with fever-triggered recurrent acute liver failure
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
| 3 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with fever-triggered recurrent acute liver failure and his family member
Key exclusion criteria
other than above described
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Matsuda |
Organization
Kawasaki Medical School
Division name
Department of Pathophysiology and Metabolism
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama JAPAN
TEL
086-462-1111
matsujun@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Matsuda |
Organization
Kawasaki Medical School
Division name
Department of Pathophysiology and Metabolism
Zip code
701-0192
Address
577 Matsushima, Kurashiki, Okayama JAPAN
TEL
086-462-1111
Homepage URL
matsujun@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
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
Kawasaki Medical School
Address
577 Matsushima, Kurashiki, Okayama JAPAN
Tel
086-462-1111
matsujun@med.kawasaki-m.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
| 2019 | Year | 06 | Month | 01 | 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
4
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
| 2018 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 27 | Day |
Last modified on
| 2022 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042003
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
