A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: boceprevir; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]; ribavirin (Copegus]; ribavirin (Copegus]
Intervention description: 800 mg three times daily for 24, 32 or 44 weeks; 180 mcg subcutaneously once a week for 24, 32 or 44 weeks; 180 mcg subcutaneously once a week for 4 weeks; 1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks; 1000 mg or 1200 mg orally once a day for 4 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multicenter, treatment response guided study will evaluate the sustained
      virological response and safety of the triple combination therapy boceprevir, Pegasys
      (peginterferon alfa-2a) and Copegus (Ribavirin) in previously untreated patients with
      genotype 1 chronic hepatitis C. In the lead-in phase, patients will receive a dual
      combination therapy of Pegasys and Copegus for 4 weeks. In the following triple combination
      therapy phase, 800 mg boceprevir, 180 mcg Pegasys and 1000-1200 mg Copegus will be
      administered for 24, 32 or 44 weeks; the duration depending on the patient's treatment
      response. The anticipated time on study treatment is up to 48 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >/=18 years of age

          -  Chronic liver disease consistent with chronic hepatitis C, genotype 1 infection

          -  Serum HCV RNA quantifiable at screening

          -  Patients who have not been previously treated with pegylated interferon (IFN),
             standard IFN, RBV or any direct acting anti-viral agent

          -  Compensated liver disease (Child-Pugh Grade A clinical classification for patients
             with cirrhosis: total score </=6)

          -  Negative urine or blood pregnancy test (for women of childbearing potential)

        Exclusion Criteria:

          -  Women with ongoing pregnancy or breast feeding

          -  Male partners of women who are pregnant

          -  Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment
             </=6 months prior to the first dose of study drug

          -  Any investigational drug </=6 weeks prior to the first dose of study drug

          -  History or other evidence of decompensated liver disease

          -  History or other evidence of a medical condition associated with chronic liver disease
             other than chronic hepatitis C

          -  Signs or symptoms of hepatocellular carcinoma

          -  Co-infection with HCV genotypes other than genotype 1

          -  Co-infection with hepatitis A, hepatitis B, and/or human immunodeficiency virus (HIV)

          -  Any patient with an increased risk for anemia

          -  History of severe psychiatric disease

          -  History of immunologically mediated, chronic pulmonary, or severe cardiac disease

          -  Current diseases that are not adequately controlled