UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007198 |
|---|---|
| Receipt number | 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 | 2023/08/10 10:37:26 |
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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 | Ryosuke |
| Middle name | |
| Last name | Tateishi |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
tateishi-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Minami |
Organization
The University of Tokyo Hospital
Division name
Department of Gastroenterology
Zip code
1138655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
tminami-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Ethics Committee
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo
Tel
03-3815-5411
ethics@m.u-tokyo.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
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
200
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
Completed
Date of protocol fixation
| 2011 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2011 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
After analysis of the antiviral effect, a follow-up observation on carcinogenesis after viral eradication was made.
Management information
Registered date
| 2012 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008477
| Research Plan | |
|---|---|
| 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 |
