UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011105 |
|---|---|
| Receipt number | R000013008 |
| Scientific Title | Virological efficacy and safety of telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis |
| Date of disclosure of the study information | 2013/07/03 |
| Last modified on | 2013/09/04 17:38:59 |
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Basic information
Public title
Virological efficacy and safety of telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis
Acronym
Telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis
Scientific Title
Virological efficacy and safety of telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis
Scientific Title:Acronym
Telaprevir-based triple therapy for chronic hepatitis C patients with advanced fibrosis
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to evaluate the efficacy and safety of telaprevir-based triple therapy for advanced fibrosis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sustained virological response
Key secondary outcomes
Predictors of SVR
Adverse effects
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
Advanced fibrosis in histology
Key exclusion criteria
Positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen
Hepatic decompensation (Child B or C)
Excessive active alcohol consumption
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Hayashi |
Organization
The Kyushu University Liver Disease Study (KULDS) Group
Division name
Kyushu University Hospital
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5909
hayashij@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichi Ogawa |
Organization
The Kyushu University Liver Disease Study (KULDS) Group
Division name
Department of General Internal Medicine, Kyushu University Hospital
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5909
Homepage URL
eogawa@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
The Kyushu University Liver Disease Study (KULDS) Group
Institute
Department
Personal name
Funding Source
Organization
Kyushu University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2011 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2013 | Year | 09 | Month | 04 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 04 | Day |
Other
Other related information
For patients with advanced fibrosis, TVR-based triple therapy greatly improves SVR rates compared to the dual therapy with PEG-IFN alpha and RBV despite the risk of severe adverse effects.
Management information
Registered date
| 2013 | Year | 07 | Month | 03 | Day |
Last modified on
| 2013 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013008
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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