UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024307 |
|---|---|
| Receipt number | 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 17:13:20 |
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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
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
akikuchi-thk@umin.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027993
