A Study of Predictors of the Effectiveness of Pegylated Interferon in a Cohort of Participants With Hepatitis C

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Treatments: Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Study type: Observational

Funder types: Industry

Identifiers

NCT01659567

ML25544

Details and patient eligibility

About

This prospective observational study will investigate predictive values of virological response in pegylated interferon alfa-2a (Pegasys)/ribavirin (Copegus) treatment-naive participants with chronic hepatitis C. Participants will be treated with pegylated interferon alfa-2a and ribavirin as prescribed by the physician. Data will be collected for a maximum of 96 weeks.

Enrollment: 516 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of chronic hepatitis C infection

Exclusion criteria

• Co-infection with human immunodeficiency virus (HIV) and/or hepatitis B
• Participants previously treated with pegylated interferon alfa-2a/ribavirin
• Participation in another clinical study within 30 days prior to study start of ML25544

Trial design

516 participants in 1 patient group

Chronic Hepatitis C

Description:

Participants with chronic hepatitis C, treated with pegylated interferon alfa-2a (Pegasys) and ribavirin (Copegus) according to the current standard of care and in line with current summaries of product characteristics/local labelling, will be observed for up to 96 weeks.

Treatment:

Drug: Ribavirin

Drug: Pegylated Interferon Alfa-2a