An Observational Study of Pegasys (Peginterferon Alfa-2a) Plus Ribavirin Based Regimens in Patients With Chronic Hepatitis C With Previous Treatment Failure

• Status: Terminated
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This prospective, national, multicenter, observational study will evaluate in routine clinical practice the efficacy and safety of re-treatment with Pegasys (peginterferon alfa-2a) plus ribavirin or regimens containing direct-acting antivirals in participants with chronic hepatitis C who failed previous treatment. Participants will be followed for the duration of their treatment (24, 48 or 72 weeks) and for 24 weeks of follow-up.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Adult participants, >/= 18 years of age

• Participants with chronic hepatitis C who have been previously treated with pegylated interferon, standard interferon, ribavirin

• No contra-indications to pegylated interferon and ribavirin therapy or to the treatment regimen containing DAAs as detailed in the local label

• Treatment in line with summary of Product Characteristics/local labeling for Pegasys/ribavirin and DAAs, in particular:

• Positive serum hepatitis C virus (HCV) ribonucleic acid (RNA)

• Fertile males and females receiving ribavirin must use two forms of contraception during treatment with Pegasys/ribavirin and until 6 months post-treatment

• No co-infection with hepatitis B or human immunodeficiency virus (HIV)

Exclusion Criteria:

• History or other evidence of a medical condition associated with chronic liver disease other than chronic hepatitis C

• History of neurological disease

• History of severe psychiatric disease

• Decompensated diabetes

• History of immunologically mediated disease

• History of severe cardiac disease

• History or evidence of severe chronic pulmonary disease

• Inadequate hematologic function

• Pregnant or breastfeeding women

• Male partners of pregnant women