UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012731 |
|---|---|
| Receipt number | R000014872 |
| Scientific Title | Peg-IFN-alfa/Ribavirin/Simeprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and Duration of therapy |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2013/12/30 09:26:57 |
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Basic information
Public title
Peg-IFN-alfa/Ribavirin/Simeprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and Duration of therapy
Acronym
Peg-IFN-alfa/Ribavirin/Simeprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and Duration of therapy
Scientific Title
Peg-IFN-alfa/Ribavirin/Simeprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and Duration of therapy
Scientific Title:Acronym
Peg-IFN-alfa/Ribavirin/Simeprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and Duration of therapy
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine | Gene |
Interventions/Control_1
IL28B gene major and relapse of previous treatment/first treatment patient with intrahepatic IFN stimulating gene index<3.5: 12 week Peg-IFN-alfa/Ribavirin/Simeprevir therapy following 12week Peg-IFN-alfa/Ribavirin therapy
Interventions/Control_2
IL28B gene major and non-response of previous treatment/first treatment patient with intrahepatic IFN stimulating gene index 3.5 and over: 12 week Peg-IFN-alfa/Ribavirin/Simeprevir therapy following 12week Peg-IFN-alfa/Ribavirin therapy
Interventions/Control_3
IL28B gene major and non-response of previous treatment/first treatment patient with intrahepatic IFN stimulating gene index 3.5 and over: 12 week Peg-IFN-alfa/Ribavirin/Simeprevir therapy following 36 week Peg-IFN-alfa/Ribavirin therapy
Interventions/Control_4
L28B gene minor and relapse of previous treatment/first treatment patient with intrahepatic IFN stimulating gene index<3.5: 12 week Peg-IFN-alfa/Ribavirin/Simeprevir therapy following 12week Peg-IFN-alfa/Ribavirin therapy
Interventions/Control_5
IL28B gene minor and relapse of previous treatment/first treatment patient with intrahepatic IFN stimulating gene index<3.5: 12 week Peg-IFN-alfa/Ribavirin/Simeprevir therapy following 36 week Peg-IFN-alfa/Ribavirin therapy
Interventions/Control_6
IL28B gene minor and non-response of previous treatment/first treatment patient with intrahepatic IFN stimulating gene index 3.5 and over: 12 week Peg-IFN-alfa/Ribavirin/Simeprevir therapy following 36 week Peg-IFN-alfa/Ribavirin therapy
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
chronic hepatitis C
serogroup1 and high viral load
Key exclusion criteria
contraindication of Peg-IFN/Ribavirin/Telaprevir therapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shuichi Kaneko |
Organization
Kanazawa University
Division name
Graduate school of medicine
Zip code
Address
13-1 Takara-Machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2235
shimakami@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuro Shimakami |
Organization
Kanazawa University
Division name
University Hospital
Zip code
Address
13-1 Takaramachi, Kanazawa
TEL
076-265-2235
Homepage URL
shimakami@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
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
| 2014 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 30 | Day |
Last modified on
| 2013 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014872
