An Observational Study on Predictive Factors of Response in Patients With Chronic Hepatitis C Treated With Pegasys (Peginterferon Alfa-2a) and Ribavirin

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01392742

ML25670

Details and patient eligibility

About

This observational study will evaluate predictors of early on-treatment response and sustained virological response in patients with chronic hepatitis C receiving Pegasys (peginterferon alfa-2a) and ribavirin. Data will be collected from patients on treatment (24 or 48 weeks) and 24 weeks after the end of treatment.

Enrollment: 443 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients, >/= 18 years of age
• Serologically confirmed chronic hepatitis C (all genotypes)
• Treatment with Pegasys and ribavirin according to the current standard of care and in line with current summaries of product characteristics (SPCs)/local labelling

Exclusion criteria

• Coinfection with HIV and/or hepatitis B
• Contraindications according to the SPC for Pegasys/ribavirin

Trial design

443 participants in 1 patient group

Cohort