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

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: ribavirin (Copegus]; Drug: peginterferon alfa-2a [Pegasys]; Drug: boceprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591460

MV28073

2011-004810-41 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 2 patient groups

Dual Combination Therapy

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: ribavirin (Copegus]

Drug: ribavirin (Copegus]

Drug: peginterferon alfa-2a [Pegasys]

Triple Combination Therapy

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: boceprevir

Drug: ribavirin (Copegus]

Drug: ribavirin (Copegus]

Drug: peginterferon alfa-2a [Pegasys]