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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036860
Receipt No. 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 2019/05/27

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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
Email 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
Email matsujun@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

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
Email 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 No longer recruiting
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 12 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
2019 Year 05 Month 27 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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