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

Roche

Status: Terminated

Conditions: Hepatitis C, Chronic

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

Study type: Observational

Funder types: Industry

Identifiers

NCT01798576

ML28498

Details and patient eligibility

About

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.

Enrollment: 282 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

282 participants in 1 patient group

Pegylated interferon alfa-2a

Description:

Participants with chronic hepatitis C with previous treatment failure received combination therapy with pegylated interferon alfa-2a plus ribavirin or treatment regimens containing direct-acting anti-viral (DAAs)

Treatment:

Drug: Ribavirin

Drug: Pegylated Interferon alfa-2a