A Triple Combination Therapy Study of Boceprevir, Pegasys and Copegus in Previously Untreated Patients With Genotype 1 Chronic Hepatitis C

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

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
• 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

• Any investigational 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