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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000013302
Receipt No. R000015514
Scientific Title Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C.
Date of disclosure of the study information 2014/03/03
Last modified on 2018/09/02

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Basic information
Public title Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C.
Acronym Comparison of peginterferon alfa-2a versus peginterferon alfa-2b in simepurevir therapy.
Scientific Title Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C.
Scientific Title:Acronym Comparison of peginterferon alfa-2a versus peginterferon alfa-2b in simepurevir therapy.
Region
Japan

Condition
Condition Chronic hepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 efficacy and safety
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes SVR ratio
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 alfa 2a
Interventions/Control_2 alfa 2b
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
75 years-old >
Gender Male and Female
Key inclusion criteria over 20 years old and under 75 years old
Key exclusion criteria there is no problem about randomaization
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Honda
Organization Oita University
Division name Department of gastroenterology
Zip code
Address Yufu-shi, Hasama-machi
TEL 097-54904411
Email hondak@oita-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Honda
Organization Oita Hepatitis C Study
Division name Gastroenterology
Zip code
Address Yufu-shi, Hasama-machi
TEL 097-549-4411
Homepage URL
Email hondak@oita-u.ac.jp

Sponsor
Institute Oita hepatitis C study
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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 03 Month 03 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 Preinitiation
Date of protocol fixation
2014 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 03 Day
Last follow-up date
2016 Year 03 Month 31 Day
Date of closure to data entry
2016 Year 03 Month 31 Day
Date trial data considered complete
2018 Year 09 Month 01 Day
Date analysis concluded
2018 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2014 Year 02 Month 28 Day
Last modified on
2018 Year 09 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015514

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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