UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045086 |
|---|---|
| Receipt number | R000051501 |
| Scientific Title | The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization |
| Date of disclosure of the study information | 2021/08/06 |
| Last modified on | 2022/10/22 23:06:00 |
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Basic information
Public title
The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization
Acronym
The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization
Scientific Title
The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization
Scientific Title:Acronym
The comparative study of the efficacy and safety of Simeprevir sodium at investigational stage and after marketing authorization
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare clinical data on Simeprevir sodium between clinical trials and after marketing authorization, and to identify factors contributing to different efficacy and safety outcomes of the drug
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The proportion of subjects who meet the inclusion/exclusion criteria of clinical trials
2. The proportion of unavailable data on the case report form
3. Differences in baseline demographic characteristics
4. The proportion of subjects who achieved Sustained Virological Response (SVR) for 12 weeks and for 24 weeks
5. The proportion of subjects who completed 24-week treatment regimen
6. Frequency of ordering laboratory tests and other to monitor the subjects
7. Frequency and severity of adverse drug events
8. Exploratory sub-group analyses of efficacy and safety of the drug
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects who were administered simeprevir sodium from December 2013 to September 2014 in Shimane Prefecture, Japan
Key exclusion criteria
Subjects who declined use of their medical records for the study
Target sample size
98
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Seki |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Medical Informatics
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-city, Shimane 693-8501 Japan
TEL
0853-20-2171
sekim@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Seki |
Organization
Shimane University
Division name
Faculty of Medicine, Department of Medical Informatics
Zip code
693-8501
Address
89-1 Enya-cho, Izumo-city, Shimane 693-8501 Japan
TEL
0853-20-2171
Homepage URL
sekim@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
Shimane University
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
Medical Research Ethics Committee, Shimane University Faculty of Medicine
Address
89-1 Enya-cho, Izumo-city, Shimane 693-8501 Japan
Tel
0853-20-2515
kenkyu@med.shimane-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
島根大学医学部附属病院（島根県）
大田市立病院（島根県）
松江赤十字病院（島根県）
公立邑智病院（島根県）
松江市立病院（島根県）
出雲市立総合医療センター（島根県）
済生会江津総合病院（島根県）
安来市立病院（島根県）
益田赤十字病院（島根県）
島根県立中央病院（島根県）
独立行政法人国立病院機構 浜田医療センター（島根県）
医療法人好生堂 和﨑医院（島根県）
益田地域医療センター医師会病院（島根県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 08 | Month | 06 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 06 | Month | 20 | Day |
Date trial data considered complete
| 2022 | Year | 10 | Month | 20 | Day |
Date analysis concluded
Other
Other related information
Multi-centre retrospective study
Management information
Registered date
| 2021 | Year | 08 | Month | 06 | Day |
Last modified on
| 2022 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051501
| Research Plan | |
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| 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 |
