Efficacy and Safety of 24 vs 48 Weeks of Pegetron® (Peginterferon Alfa-2b + Ribavirin) in Naïve Genotype 1 Hepatitis C (Study P05016)(TERMINATED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Combination of pegylated interferon alfa-2b (PEG) and ribavirin (RBV)
Intervention description: Powder for Solution in Redipen® (pegylated interferon alfa-2b) (80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 or 48 weeks
200 mg ribavirin capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 or 48 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a Phase IIIB randomized, controlled, multi-centre, open-label study of 24 versus 48
      weeks therapy with Pegetron® (peginterferon alfa-2b + ribavirin) at standard doses in naïve
      Hepatitis C Virus (HCV) genotype 1 high viral load (HVL) participants who are Hepatitis C
      Virus-Ribonucleic Acid (HCV-RNA) negative at Week 4. HVL will be defined as HCV-RNA of
      >600,000 IU/mL prior to the initiation of therapy. Participants with genotype 1 baseline HVL
      prescribed Pegetron® (peginterferon and ribavirin) in the usual manner in accordance with the
      marketing authorization and who are viral negative at Week 4 will be randomized at Week 8 to
      receive a total of 24 or 48 weeks of therapy. Participants will be required to have their
      baseline and Week-12 viral load analyzed by the same local laboratory using the standard of
      care test used by the site. Qualitative testing at Week 4, 8, 16-20, 24, and 48 may be
      conducted either by local laboratory or a central laboratory identified by the sponsor using
      an assay specified by the sponsor. No additional interventions outside of the clinic's
      standard of care and the conditions of the Canadian product monograph for Pegetron® will be
      applied to participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must demonstrate willingness to participate in the study.

          -  Diagnosed with chronic HCV.

          -  Between 18 and 65 years of age of either gender and of any race.

          -  a. HCV positive, >600,000 IU/mL at baseline AND b. Genotype 1.

          -  Suitable for treatment with Pegetron® per the Canadian product monograph.

          -  Investigator has already decided to treat with PEGETRON REDIPEN®

        1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.

          -  HCV-RNA negative at treatment week 4.

          -  Meet certain minimum laboratory values at the week 4 screening visit.

          -  Women of childbearing potential and male partners must agree to use a medically
             accepted method of contraception prior to screening, while receiving
             protocol-specified medication, and for 6 months after stopping the medication.
             Acceptable methods of contraception include condoms (male or female) with or without a
             spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed
             IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g.
             hysterectomy or tubal ligation).

        Exclusion Criteria:

          -  Had previous interferon-based therapy for Chronic Hepatitis C.

          -  Active Hepatitis B virus (HBV) infection.

          -  Human Immunodeficiency Virus (HIV) antibody positive.

          -  Cirrhotic (Stage 4 on Metavir system).

          -  Uncontrolled history or current severe depression or psychoses.

          -  Uncontrolled epilepsy.

          -  Use of illicit drugs.

          -  History of non-compliance to medical regimens.

          -  Liver disease other than from chronic hepatitis C.

          -  Participating in any other clinical study.

          -  Used any investigational drugs within 30 days of screening.

          -  Participants weighing < 40 kg or > 125 kg.

          -  Pregnant women or women who plan to become pregnant or sexual partners of women who
             want to become pregnant.