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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000012731
Receipt No. 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

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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
Email 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
Email shimakami@m-kanazawa.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014872

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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