A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2a; Ribavirin
Intervention description: Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.; For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 272.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, non-randomized, single arm study will provide treatment or re-treatment with
      Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to
      patients with chronic hepatitis C infection. Patients who have received prior Pegasys
      monotherapy or combination therapy or who were considered eligible for treatment with Pegasys
      in previous donor protocols will be eligible to participate in this study. Treatment will be
      on investigator's decision according to the approved label for up to 48 weeks, with a 24-week
      safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age.

          -  Chronic hepatitis C.

          -  Compensated liver disease (Child-Pugh Class A).

          -  Previous participation in a donor protocol in which treatment or re-treatment with
             Pegasys alone or in combination with Copegus was recommended or deemed appropriate
             after study completion.

          -  Have completed safety and efficacy assessments as defined in the donor protocol
             without violation or any major deviation.

          -  Have not received any other anti-hepatitis C virus treatment after the completion of
             the donor protocol.

          -  For females of childbearing potential, a negative pregnancy test within 24 hours prior
             to first dose of study drug.

          -  Fertile patients (male and female) must use 2 reliable forms of contraception
             (combined) for the duration of the study (treatment and follow-up) in accordance with
             the locally approved label for Copegus.

        Exclusion Criteria:

          -  Pregnant or breastfeeding women.

          -  Male partners of women who are pregnant.

          -  Patients with hemoglobinopathies.

          -  Hepatic decompensation (Child-Pugh Class B or C) before or during treatment.

          -  Non-responder patients (defined as patients previously treated with Pegasys and
             Copegus combination therapy at standard doses for at least 12 weeks who did not
             achieve at least a 2-log drop from their baseline viral load).

          -  Liver disease other than chronic hepatitis C, including hepatic carcinoma.