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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000019400
Receipt No. R000022441
Scientific Title Prospective study of Sofosbuvir and Ledipasvir for HCV genotype 1 infected Japanese patients
Date of disclosure of the study information 2015/12/01
Last modified on 2019/04/22

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Basic information
Public title Prospective study of Sofosbuvir and Ledipasvir for HCV genotype 1 infected Japanese patients
Acronym IFN free SL study
Scientific Title Prospective study of Sofosbuvir and Ledipasvir for HCV genotype 1 infected Japanese patients
Scientific Title:Acronym IFN free SL study
Region
Japan

Condition
Condition Genotype 1 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 1 infected patients with chronic liver disorder
Patients satisfied the public indication for sofosbuvir and ledipasvir
Key exclusion criteria Pregnant woman
Decompensated cirrhosis
Hepatocellular carcinoma
Renal impairement (eGFR<30ml/min/1.73m2)
Doctors judge as inappropriate
Target sample size 400

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 1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586, 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 12 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 Open public recruiting
Date of protocol fixation
2015 Year 09 Month 01 Day
Date of IRB
2015 Year 09 Month 01 Day
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
2022 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/LDV from October 1 2015 to December 31 2019.
Examination of HCV viral load, ALT, Platelet, AFP, and M2BPGi

Management information
Registered date
2015 Year 10 Month 19 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022441

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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