UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C.
Title of the study (Brief title)	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	Koichi Honda
Organization	Oita University
Division name	Department of gastroenterology
Address	Yufu-shi, Hasama-machi
TEL	097-54904411
Email	hondak@oita-u.ac.jp

Public contact
Name of contact person	Koichi Honda
Organization	Oita Hepatitis C Study
Division name	Gastroenterology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2014 Year 02 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000015514