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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034735
Receipt No. R000039600
Official scientific title of the study Long-term effect of interferon-free treatment in subjects with hepatitis C virus (HCV)-related decompensated cirhosis
Date of disclosure of the study information 2018/11/01
Last modified on 2018/11/01

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Basic information
Official scientific title of the study Long-term effect of interferon-free treatment in subjects with hepatitis C virus (HCV)-related decompensated cirhosis
Title of the study (Brief title) DAA for decompensatd cirrhosis
Region
Japan

Condition
Condition decompensated cirrhosis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigation of the long-term efficacy for velpatasvir and sofosbuvir with or without ribavirin therapy for Hepatitis C Virus infection in patients with decompensated cirrhosis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Child-Pugh score, MELD score
HCC occurence rate
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 Patients in clinical trial of Velpatasvir/Sofosbuvir with or without ribavirin in Japan
Key exclusion criteria none
Target sample size 102

Research contact person
Name of lead principal investigator Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person Ryotaro Sakamori
Organization Osaka University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Address 2-2 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Homepage URL
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization Osaka University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 11 Month 01 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 05 Day
Anticipated trial start date
2018 Year 10 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none

Management information
Registered date
2018 Year 11 Month 01 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039600

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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