Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 117
Healthy volunteers: no

Brief summary:
This is an uncontrolled, non-randomized, open-label, multinational study designed to evaluate the efficacy and safety of PegIntron plus Rebetol in subjects with chronic hepatitis C. The study is designed to determine the proportion of chronic hepatitis C genotype 1 subjects who did not respond to previous treatment with Pegasys 180µg QW plus ribavirin, that will achieve sustained virological response (SVR) when treated with PegIntron plus Rebetol.

Detailed description:

Arms:
arm 1: PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks

Interventions: intervention 1: PegIntron (peginterferon alfa-2b) intervention 2: Rebetol (ribavirin)
Intervention descriptions: intervention 1: Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks intervention 2: 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for up to 48 weeks

Protocol document: