UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016769 |
|---|---|
| Receipt number | R000019462 |
| Scientific Title | A prospective and retrospective multicenter cohort study of Daclatasvir + Asunaprevir combination therapy for chronic hepatitis C with and without liver cirrhosis |
| Date of disclosure of the study information | 2015/03/11 |
| Last modified on | 2024/03/19 10:18:13 |
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Basic information
Public title
A prospective and retrospective multicenter cohort study of Daclatasvir + Asunaprevir combination therapy for chronic hepatitis C with and without liver cirrhosis
Acronym
SMART-C V3
Scientific Title
A prospective and retrospective multicenter cohort study of Daclatasvir + Asunaprevir combination therapy for chronic hepatitis C with and without liver cirrhosis
Scientific Title:Acronym
SMART-C V3
Region
| Japan |
Condition
Condition
chronic hepatitis C with and without liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of Daclatasvir+Asunaprevir combination therapy for chronic hepatitis C with and without liver cirrhosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
sustained virological response
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
1) Those who gave written informed consent for participation
2) Those with HCV-RNA genotype 1 or serotype 1
3) Those who are not contraindicated for Daclatasvir and Asunaprevir
4) Those not suitable or intolerant for interferon therapy
Key exclusion criteria
None
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Tateishi |
Organization
Department of Gastroenterology, the University of Tokyo Graduate School of Medicine
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 Department of Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology, Graduate School of Medicine, the University of Tokyo
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo Hospital
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 11 | 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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 03 | Month | 15 | 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
To collect data before treatment, 4, 8, 12 and 24 weeks after the initiation of treatment, 12 and 24 weeks after the end of treatment.
Sustained virological response (SVR)
Adverse event
Management information
Registered date
| 2015 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019462
