An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01671046

First received: August 20, 2012

Last updated: May 13, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 20, 2012

Last Updated Date

May 13, 2013

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Correlation of liver elasticity evolution with viral kinetics [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01671046 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Correlation of liver fibrosis stages with sustained virological response (SVR) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Correlation of patients characteristics with sustained virological response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Hepatic transient elastography (M-transducer) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Hepatic transient elastography (XL-transducer) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Correlation of hepatic steatosis score with sustained virological response [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Safety: incidence of adverse events [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection

Official Title ^ICMJE

Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients

Brief Summary

This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Biopsy of the liver

Sampling Method

Probability Sample

Study Population

Patients with chronic hepatitis C

Condition ^ICMJE

Hepatitis C, Chronic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Cohort

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

294

Estimated Completion Date

November 2015

Estimated Primary Completion Date

November 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Adult patients, >/= 18 years of age
Chronic Hepatitis C infection (mono-infection or co-infection with human immunodeficiency virus [HIV])
Detectable level of hepatitis C RNA
Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines
Last liver biopsy performed no later than 3 months prior to enrolment to study

Exclusion Criteria:

Co-infection with hepatitis B virus
Previous treatment with pegylated interferon and ribavirin
Participation in another clinical study in the last 12 months prior to study start

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML27944 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01671046

Other Study ID Numbers ^ICMJE

ML27944

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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