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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000007198
Receipt No. R000008477
Scientific Title Prospective Multicenter Cohort Study of Peginterferon, Ribavirin and Telaprevir for Chronic Hepatitis C
Date of disclosure of the study information 2012/02/01
Last modified on 2016/06/09

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Basic information
Public title Prospective Multicenter Cohort Study of Peginterferon, Ribavirin and Telaprevir for Chronic Hepatitis C
Acronym SMART-C V2
Scientific Title Prospective Multicenter Cohort Study of Peginterferon, Ribavirin and Telaprevir for Chronic Hepatitis C
Scientific Title:Acronym SMART-C V2
Region
Japan

Condition
Condition Chronic Hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To prospectively assess the efficacy of peginterferon, ribavirin and telaprevir combination therapy for chronic hepatitis C
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Sustained virologic response
Key secondary outcomes Safety

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chronic Hepatitis C with Serogroup 1
HCV-RNA >= 5.0 logIU/mL
Those who have the indication for peginterferon, ribavirin and telaprevir combination therapy
Key exclusion criteria Not specified
Target sample size 750

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Koike
Organization The University of Tokyo, Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-5689-4016
Email koike-1im@h.u-tokyo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryosuke Tateishi
Organization The University of Tokyo Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email tateishi-tky@umin.ac.jp

Sponsor
Institute Department of Gastroenterology, The University of Tokyo, Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology, the University of Tokyo, Graduate School of Medicine
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 遠藤康夫内科クリニック(東京都)
三菱診療所(東京都)
社会保険中央総合病院(東京都) 
NTT東日本関東病院 (東京都)
国立国際医療研究センター病院(東京都) 
国立病院機構災害医療センタ(東京都)ー 
東芝病院(東京都) 
調布東山病院(東京都) 
東京厚生年金病院(東京都) 
せんぽ東京高輪病院(東京都) 
小平記念東京日立病院(東京都) 
癌研有明病院(東京都) 
河北総合病院(東京都) 
東京逓信病院(東京都) 
三楽病院(東京都) 
清川病院(東京都)
帝京大学医学部(東京都) 
三井記念病院(東京都) 
JR東京総合病院(東京都) 
東京警察病院(東京都) 
関東中央病院(東京都) 
日本赤十字社医療センター(東京都) 
東京大学医科学研究所病院(東京都) 
三軒茶屋病院(東京都) 
関東労災病院(神奈川県) 
国立国際医療研究センター国府台病院(千葉県) 
館山病院(千葉県)
日立総合病院(茨城県) 
倉井清彦内科医院(東京都) 
東京西徳州会病院(東京都)
丸の内クリニック(東京都)
杏雲堂病院(東京都)
昭和大学藤が丘病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2012 Year 02 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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Recruiting

Management information
Registered date
2012 Year 02 Month 01 Day
Last modified on
2016 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008477

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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