UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016639
Receipt number 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 20:01:10

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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 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


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

Value
https://center6.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