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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037575
Receipt No. R000042836
Scientific Title Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Date of disclosure of the study information 2019/08/01
Last modified on 2019/08/01

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Basic information
Public title Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Acronym Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Scientific Title Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Scientific Title:Acronym Efficacy and safety of interferon-free treatment in patients with chronic hepatitis C
Region
Japan

Condition
Condition chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate treatment effects of interferon-free treatment on prognosis, and factors contributing to treatment effects
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sustained virological response rates at 24weeks after the end of treatment
Key secondary outcomes factors contributing to sustained virological response
appearance of RAS(resistant associated substitutions)
occurrence of hepatocellular carcinoma
factors associated with occurrence of hepatocellular carcinoma
changes in liver fibrosis and liver function
life prognosis

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 1. Patients who are 20 years of age or older
2. Patients with chronic hepatitis C
3. Patients who are treated with interferon-free treatment
Key exclusion criteria 1. Patients treated with contraindicated drug together with direct acting antivirals
2. Patients who were judged inadequate to participate by researchers.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Takehara
Organization Graduate school of medicine, Osaka university
Division name department of gastroenterology and hepatology
Zip code 565-0871
Address 2-2, Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Email takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Ryotaro
Middle name
Last name Sakamori
Organization Graduate school of medicine, Osaka university
Division name department of gastroenterology and hepatology
Zip code 565-0871
Address 2-2, Yamadaoka, Suita, Osaka
TEL 06-6879-3621
Homepage URL
Email sakamori@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka university
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University Clinical Research Review Committee
Address 2-2, Yamadaoka, Suita, Osaka
Tel 06-6210-8289
Email rinri@hp-crc.med.osaka-u.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
2019 Year 08 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
2017 Year 02 Month 01 Day
Date of IRB
2017 Year 05 Month 29 Day
Anticipated trial start date
2017 Year 12 Month 06 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 none

Management information
Registered date
2019 Year 08 Month 01 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042836

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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