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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023115
Receipt No. R000026643
Scientific Title HCV kinetics by the two different real-time HCV assays in DAA-based treatment
Date of disclosure of the study information 2016/07/11
Last modified on 2017/01/10

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Basic information
Public title HCV kinetics by the two different real-time HCV assays in DAA-based treatment
Acronym Viral kinetics in DAA-based treatment
Scientific Title HCV kinetics by the two different real-time HCV assays in DAA-based treatment
Scientific Title:Acronym Viral kinetics in DAA-based treatment
Region
Japan

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

Objectives
Narrative objectives1 This study was carried out to compare the performance characteristics of the different real-time HCV RNA assays for the analysis of the DAA-based treatment outcome of chronic hepatitis C.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association between HCV kinetics by TaqMan and AccuGene assays and treatment outcome in DAA-based 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 Eligible patients were aged 20 years and older with confirmed chronic HCV mono-infection.
Key exclusion criteria Exclusion criteria included positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen, clinical or biochemical evidence of hepatic decompensation, and any non-HCV related liver disease,such as autoimmune hepatitis or primary biliary cirrhosis.
Target sample size 250

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 Univeristy
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
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 07 Month 11 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 08 Month 03 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective obsevational study

Management information
Registered date
2016 Year 07 Month 11 Day
Last modified on
2017 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026643

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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