Conditions: Hepatitis C
Keywords: hepatitis C HCV genotype sustained virological response rapid virological response interferon
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 116
Healthy volunteers: no

Brief summary:
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.

Detailed description:
The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.

Arms:
arm 1: continuous subcutaneous infusion for 48 weeks arm 2: continuous subcutaneous infusion for 48 weeks arm 3: continuous subcutaneous infusion for 48 weeks arm 4: subcutaneous weekly for 48 weeks

Interventions: intervention 1: interferon alfa-2b intervention 2: peginterferon alfa-2b intervention 3: ribavirin, USP intervention 4: external drug infusion pump
Intervention descriptions: intervention 1: subcutaneous continuous infusion at one of three doses for 48 weeks intervention 2: 1.5 μg/kg subcutaneous weekly for 48 weeks intervention 3: All patients will receive oral ribavirin intervention 4: pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

Protocol document: