Conditions: Hepatitis C, Chronic
Keywords: chronic hepatitis C pegylated interferon alfa-2b ribavirin Australia
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 146
Healthy volunteers: no

Brief summary:
This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.

Detailed description:

Arms:
arm 1: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks arm 2: Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks

Interventions: intervention 1: Peginterferon alfa-2b intervention 2: Peginterferon alfa-2b intervention 3: Ribavirin intervention 4: Ribavirin
Intervention descriptions: intervention 1: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks intervention 2: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 3: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks intervention 4: 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks

Protocol document: