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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016639
Receipt No. R000019315
Scientific Title Peg-IFN-alfa 2b/Ribavirin/Vaniprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and duration of therapy
Date of disclosure of the study information 2015/02/26
Last modified on 2015/02/25

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Basic information
Public title Peg-IFN-alfa 2b/Ribavirin/Vaniprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and duration of therapy
Acronym Peg-IFN-alfa 2b/Ribavirin/Vaniprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and duration of therapy
Scientific Title Peg-IFN-alfa 2b/Ribavirin/Vaniprevir therapy for chronic hepatitis C: Effectiveness prediction by gene analysis and duration of therapy
Scientific Title:Acronym Peg-IFN-alfa 2b/Ribavirin/Vaniprevir 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 9
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-alfa2b/Ribavirin/Vaniprevir therapy following 12week Peg-IFN-alfa 2b/Ribavirin therapy
Interventions/Control_2 IL28B gene major and first treatment patient with intrahepatic IFN stimulating gene index 3.5 and over: 12 week Peg-IFN-alfa 2b/Ribavirin/Vaniprevir therapy following 12week Peg-IFN-alfa 2b/Ribavirin therapy
Interventions/Control_3 IL28B gene major and first treatment patient with intrahepatic IFN stimulating gene index 3.5 and over: 12 week Peg-IFN-alfa2b/Ribavirin/Vaniprevir therapy following 36 week Peg-IFN-alfa 2b/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 2b/Ribavirin/Vaniprevir therapy following 12week Peg-IFN-alfa2b/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 2b/Ribavirin/Vaniprevir therapy following 36 week Peg-IFN-alfa 2b/Ribavirin therapy
Interventions/Control_6 IL28B gene minor and first treatment patient with intrahepatic IFN stimulating gene index 3.5 and over: 12 week Peg-IFN-alfa 2b/Ribavirin/Vaniprevir therapy following 36 week Peg-IFN-alfa 2b/Ribavirin therapy
Interventions/Control_7 IL28B gene major and non-responce of previous treatment:24 week Peg-IFN-alfa2b/Ribavirin/Vaniprevir
Interventions/Control_8 IL28B gene major and non-responce of previous treatment: 24 week Peg-IFN-alfa2b/Ribavirin/Vaniprevir therapy following 24 week Peg-IFN-alfa 2b/Ribavirin therapy
Interventions/Control_9 IL28B gene minor and non-responce of previous treatment: 24 week Peg-IFN-alfa2b/Ribavirin/Vaniprevir therapy following 24 week Peg-IFN-alfa 2b/Ribavirin therapy
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
Key exclusion criteria contraindication of Peg-IFN/Ribavirin/Vaniprevir therapy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuro Shimakami
Organization Kanazawa University Hospital
Division name Department of Gastrotenterology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa
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 Hospital
Division name Department of Gastrotenterology
Zip code
Address 13-1, Takaramachi, Kanazawa, Ishikawa
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 黒部市民病院(富山県)
富山労災病院(富山県)
厚生連滑川病院(富山県)
富山県立中央病院(富山県)
おぎの内科医院(富山県)   
富山市民病院(富山県)         
厚生連高岡病院(富山県)      
市立砺波総合病院(富山県)      
公立能登総合病院(石川県)    
恵寿総合病院(石川県) 
公立羽咋病院(石川県) 
金沢医療センター(石川県) 
金沢市立病院(石川県) 
金沢赤十字病院(石川県)             
石川県済生会金沢病院(石川県)         
公立松任石川中央病院(石川県)          
金沢聖霊病院(石川県)    
能美市立病院(石川県)  
金沢有松病院(石川県) 
やわたメディカルセンター(石川県)  
河北中央病院(石川県) 
小松ソフィア病院(石川県)  
福井県済生会病院(福井県)
市立敦賀病院(福井県)
石川県立中央病院(石川県)
宇出津総合病院(石川県)
福井大学病院(福井県)
福井県立病院(福井県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 26 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
2015 Year 01 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 25 Day
Last modified on
2015 Year 02 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019315

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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