UMIN-CTR Clinical Trial

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
Email	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
Email	sekim@med.shimane-u.ac.jp

Sponsor
Institute	Shimane University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051501