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

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01671046

ML27944

Details and patient eligibility

About

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.

Enrollment: 123 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

123 participants in 1 patient group

Cohort