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

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT01671046
• Lead Sponsor: Hoffmann-La Roche

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 available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-20
• Study First Posted: 2012-08-23
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of liver elasticity evolution with viral kinetics	24 months
Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start	24 months

Secondary Outcome Measures

Name	Time	Method
Correlation of liver fibrosis stages with sustained virological response (SVR)	24 months
Correlation of hepatic steatosis score with sustained virological response	24 months
Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients	24 months
Safety: incidence of adverse events	24 months
Hepatic transient elastography (M-transducer)	24 months
Hepatic transient elastography (XL-transducer)	24 months
Correlation of patients characteristics with sustained virological response	24 months
Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy	24 months