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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012850
Receipt No. R000015016
Scientific Title Utility of non-invasive fibrosis assessment for patients with chronic hepatitis C treated with telaprevir-based triple therapy
Date of disclosure of the study information 2014/01/14
Last modified on 2014/06/27

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Basic information
Public title Utility of non-invasive fibrosis assessment for patients with chronic hepatitis C treated with telaprevir-based triple therapy
Acronym Prediction of treatment outcome by triple therapy using non-invasive fibrosis assessment
Scientific Title Utility of non-invasive fibrosis assessment for patients with chronic hepatitis C treated with telaprevir-based triple therapy
Scientific Title:Acronym Prediction of treatment outcome by triple therapy using non-invasive fibrosis assessment
Region
Japan

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

Objectives
Narrative objectives1 Utility of non-invasive fibrosis assessment for patients treated with triple therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Sustained virological response
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
75 years-old >
Gender Male and Female
Key inclusion criteria Chronic hepatitis C patients
Key exclusion criteria (1) positivity for antibody to human immunodeficiency virus or positivity for hepatitis B surface antigen; (2) clinical or biochemical evidence of hepatic decompensation (Child-Pugh B or C, ascites, bleeding varices, or encephalopathy); (3) other causes of liver disease; (4) excessive active alcohol consumption, drug abuse or severe mental disorder; (5) the presence of active cancer at entry; or (6) treatment with antiviral or immunosuppressive agents prior to enrollment
Target sample size 100

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 +81-92-642-2909
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 +81-92-642-5909
Homepage URL
Email eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute Department of General Internal Medicine, Kyushu University Hospital
Institute
Department

Funding Source
Organization Kyushu University
Organization
Division
Category of Funding Organization
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
2014 Year 01 Month 14 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
An alternative to METAVIR score by liver biopsy, non-invasive fibrosis assessments are useful options for predicting SVR by prior partial or null responders in TVR-based triple therapy.
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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 12 Month 01 Day
Last follow-up date
2014 Year 01 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded
2014 Year 05 Month 31 Day

Other
Other related information Liver biopsy and non-invasive fibrosis assessments are performed at entry. We compare the non-invasive assessment of fibrosis with liver biopsy on their ability to assess predictors of treatment outcome.

Management information
Registered date
2014 Year 01 Month 14 Day
Last modified on
2014 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015016

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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