UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012850
Receipt number 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 12:36:12

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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 or person

Institute

Department of General Internal Medicine, Kyushu University Hospital

Institute

Department

Personal name



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

Value
https://center6.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