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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024007
Receipt No. R000027640
Scientific Title Effectiveness and safety of ledipasvir and sofosbuvir for patients infected with HCV genotype 1 in clinical practices
Date of disclosure of the study information 2016/09/12
Last modified on 2017/09/16

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Basic information
Public title Effectiveness and safety of ledipasvir and sofosbuvir for patients infected with HCV genotype 1 in clinical practices
Acronym Ledipasvir and sofosbuvir treatment for HCV genotype 1 patients
Scientific Title Effectiveness and safety of ledipasvir and sofosbuvir for patients infected with HCV genotype 1 in clinical practices
Scientific Title:Acronym Ledipasvir and sofosbuvir treatment for HCV genotype 1 patients
Region
Japan

Condition
Condition Chronic hepatitis C genotype 1
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To assess the effectiveness and safety of ledipasvir/sofosbuvir treatment in multicenter, real-world cohort study
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Rates of Sustained virological response at 12 weeks after the end of treatment
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Chronic HCV genotype 1 infection
Key exclusion criteria (1)Decompensated cirrhosis (Child B/C)
(2)Autoimmune hepatitis or primary biliary cholangiris
(3)eGFR<30
(4)Positivity for antibody to HIV
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norihiro Furusyo
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Email furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiichi Ogawa
Organization Kyushu University Hospital
Division name Department of General Internal Medicine
Zip code
Address 3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5909
Homepage URL
Email eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University
Institute
Department

Funding Source
Organization None
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
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
2016 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

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 09 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 09 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 Multicenter, obsevatinal cohort study

Management information
Registered date
2016 Year 09 Month 12 Day
Last modified on
2017 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027640

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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