An Observational Study on The Prediction of Adverse Events in Patients With Chronic Hepatitis C Receiving a Long-Acting Interferon Plus Ribavirin (GUARD-C)

Roche

Status: Completed

Conditions: Hepatitis C, Chronic

Study type: Observational

Funder types: Industry

Identifiers

NCT01344889

MV22255

Details and patient eligibility

About

This observational study will assess factors leading to dose reductions/treatment discontinuations and the effect on sustained virological response in patients with chronic hepatitis C receiving a long-acting interferon (e.g. Pegasys/peginterferon alfa-2a) and ribavirin. Data will be collected from each patient for the duration of their treatment and for up to 6 months thereafter.

Enrollment: 4,459 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (according to local legislation)
• Chronic hepatitis C
• Treatment with long-acting interferon plus ribavirin
• Quantifiable HCV RNA before initiation of treatment
• No contra-indications to long-acting interferon and ribavirin therapy as detailed in the label

Exclusion criteria

• End stage renal disease
• Major organ transplantation
• Concomitant therapy with telbivudine
• Pregnant or breast-feeding females
• Male partners of pregnant females

Trial design

4,459 participants in 1 patient group

Cohort