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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024307
Receipt No. R000027993
Scientific Title Treatment of an inherited disorder of cholesterol metabolism by pathogenesis-based therapy
Date of disclosure of the study information 2016/11/01
Last modified on 2017/10/06

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Basic information
Public title Treatment of an inherited disorder of cholesterol metabolism by pathogenesis-based therapy
Acronym Treatment of an inherited disorder of cholesterol metabolism by pathogenesis-based therapy
Scientific Title Treatment of an inherited disorder of cholesterol metabolism by pathogenesis-based therapy
Scientific Title:Acronym Treatment of an inherited disorder of cholesterol metabolism by pathogenesis-based therapy
Region
Japan

Condition
Condition an inherited disorder of cholesterol metabolism
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Improvement of skin condition
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement of skin condition after 24 weeks of treatment
Key secondary outcomes Evaluation of intermediate of cholesterol in the patients' skin
Skin biopsy

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Topical application of 1% atorvastatin or control (paraben water) (24 weeks)
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
10 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Patients with an inherited disorder of cholesterol metabolism, confirmed by genetic diagnosis or sterol profile analysis of skin
Key exclusion criteria Past histroy of allergic reaction for atorvastatin
Severe hepatic disease/disorder (AST or ALT > normal limits*1.25)
During administration of Telaprevir
Women who are or may be pregnant
Participants in other clinical trials or researchs at the registration
Patients who are judged inappropriate for the trial by lead principal investigator or other participating doctors
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeo Kure
Organization Tohoku University Graduate School of Medicine
Division name Department of Pediatrics
Zip code
Address 2-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7287
Email kure@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuo Kikuchi
Organization Tohoku University Hospital
Division name Department of Pediatrics
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai
TEL 022-717-7287
Homepage URL
Email akikuchi-thk@umin.ac.jp

Sponsor
Institute Department of Pediatrics, Tohoku University Graduate School of Medicine
Institute
Department

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
Address
Tel
Email

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
2016 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 Terminated
Date of protocol fixation
2016 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 04 Day
Last follow-up date
2017 Year 10 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
2016 Year 10 Month 05 Day
Last modified on
2017 Year 10 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027993

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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