Conditions: Hepatitis C
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the efficacy of three regimens of pegylated interferon-alfa 2b (PEG-IFN) either as monotherapy or in combination with ribavirin in participants with acute hepatitis C. After 12 weeks of observation from disease onset, participants will receive one of the following regimens: (1) a 24-week course of PEG-IFN monotherapy (PEG-IFN 24); or (2) a 12-week course of PEG-IFN monotherapy (PEG-IFN-12); or (3) a 12-week course of PEG-IFN in combination with ribavirin (PEG-IFN + RVB 12). After the treatment period, participants will enter a 12-month follow-up.

Detailed description:

Arms:
arm 1: pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks arm 2: pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks arm 3: pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

Interventions: intervention 1: Pegylated interferon alfa-2b intervention 2: Ribavirin
Intervention descriptions: intervention 1: 1.5 ug/kg/week SC for 12 or 24 weeks intervention 2: Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks

Protocol document: