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

Hoffmann-La Roche123 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

123

Conditions

Hepatitis C, Chronic

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Unnamed facility

Rio de Janeiro, Rio de Janeiro, Brazil

Unnamed facility

Botucatu, São Paulo, Brazil

Unnamed facility

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start

Time frame: 24 months

Correlation of liver elasticity evolution with viral kinetics

Time frame: 24 months

Secondary Outcomes

Safety: incidence of adverse events

Time frame: 24 months

Correlation of liver fibrosis stages with sustained virological response (SVR)

Time frame: 24 months

Correlation of patients characteristics with sustained virological response

Time frame: 24 months

Hepatic transient elastography (M-transducer)

Time frame: 24 months

Hepatic transient elastography (XL-transducer)

Time frame: 24 months

Correlation of hepatic steatosis score with sustained virological response

Time frame: 24 months

Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy

Time frame: 24 months

Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients

Time frame: 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.