Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic Genotype 2 and Genotype 3
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 696
Healthy volunteers: no

Brief summary:
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\] .

Detailed description:
This is a randomized, open-label, multinational study designed to evaluate the "standard" regimen, PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.5/R (24 weeks)\], compared to a lower dose regimen, PegIntron 1.0 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg daily \[Arm PEG2b 1.0/R (24 weeks)\], using a 24 week treatment duration for both arms. Additionally, the study examined the efficacy of reduced treatment duration: PegIntron 1.5 µg/kg subcutaneously once weekly plus ribavirin 800-1200 mg for 16 weeks \[Arm PEG2b 1.5/R (16 weeks)\].

Arms:
arm 1: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks arm 2: PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks arm 3: PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks

Interventions: intervention 1: peginterferon alfa-2b (SCH 54031) intervention 2: peginterferon alfa-2b (SCH 54031) intervention 3: peginterferon alfa-2b (SCH 54031) intervention 4: ribavirin (SCH 18908) intervention 5: ribavirin (SCH 18908)
Intervention descriptions: intervention 1: 1.5 mcg/kg QW SC for 24 weeks intervention 2: 1.0 mcg/kg QW SC for 24 weeks intervention 3: 1.5 mcg/kg QW SC for 16 weeks intervention 4: 800-1200 mg daily for 24 weeks intervention 5: 800-1200 mg daily for 16 weeks

Protocol document: