UMIN-CTR Clinical Trial

Basic information
Public title	Prospective study of Sofosbuvir/Ribavirin for HCV genotype 2 infected Japanese patients
Acronym	IFN free SR study
Scientific Title	Prospective study of Sofosbuvir/Ribavirin for HCV genotype 2 infected Japanese patients
Scientific Title:Acronym	IFN free SR study
Region	Japan

Condition
Condition	Genotype 2 infected chronic liver diseases
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Efficacy and safety
Basic objectives2	Others
Basic objectives -Others	viral genome
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sustained viral response
Key secondary outcomes	Suppression of hepatocarcinogenesis

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	HCV genotype 2 infected patients with chronic liver disorders. Patients satisfied the public indication for sofosbuvir and ribavirin
Key exclusion criteria	Pregnant women Decompensated cirrhosis Hepatocellular carcinoma Renal impairment (eGFR<30) Doctors judge as inappropriate
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Akihiro Middle name Last name Tamori
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Hepatology
Zip code	5458585
Address	1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL	06-6645-3811
Email	atamori@med.osaka-cu.ac.jp

Public contact
Name of contact person	1st name Akihiro Middle name Last name Tamori
Organization	Osaka City University Graduate School of Medicine
Division name	Department of Hepatology
Zip code	5458585
Address	1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL	06-6645-3811
Homepage URL
Email	atamori@med.osaka-cu.ac.jp

Sponsor
Institute	Osaka City University and affiliated hospitals
Institute
Department

Funding Source
Organization	Osaka City University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The ethical committee, Osaka City University Hospital
Address	1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
Tel	06-6645-3435
Email	ethics@med.osaka-cu.ac.jp

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	2015 Year 11 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	Completed
Date of protocol fixation	2015 Year 07 Month 28 Day
Date of IRB	2015 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patients treated with SOF/RBV from June 1 2015 to December 31 2018 Examination for HCV viral load, AFP, and M2BPGi

Management information
Registered date	2015 Year 10 Month 19 Day
Last modified on	2022 Year 05 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022439

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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