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Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
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Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
This study is currently recruiting participants.
First Received: December 13, 2010 Last Updated: December 21, 2010
Purpose
To assess safety and tolerability of PSI-7977 400 mg and ribavirin (RBV) with and without pegylated interferon alfa 2a (PEG-IFN) in treatment naive subjects with hepatitis C (HCV) genotypes 2 or 3
Further study details as provided by Pharmasset:
Primary Outcome Measures:
· Safety and Tolerability [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]To assess the safety and tolerability of PSI-7977 400 mg and ribavirin for 12 weeks, administered with and without pegylated interferon alfa-2a (PEG-IFN) in treatment naïve subjects with HCV genotypes 2 or 3
Secondary Outcome Measures:
· HCV RNA [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]To evaluate the change in circulating HCV RNA in subjects over 12 weeks of dosing with PSI-7977 and ribavirin administered with and without PEG-IFN in treatment-naïve subjects with HCV genotypes 2 or 3
· HCV RNA [ Time Frame: Ongoing ] [ Designated as safety issue: No ]To evaluate the proportion of subjects who have HCV RNA below the limit of quantitation (LOQ) and below the limit of detection (LOD) at various time points in the study
· Sustained Virologic Response (SVR) [ Time Frame: SVR 12 and SVR 24 ] [ Designated as safety issue: No ]To evaluate the sustained virologic response at 12 (SVR12) and 24 (SVR24) weeks following completion of all treatment
· Resistance [ Time Frame: Ongoing ] [ Designated as safety issue: No ]To evaluate the emergence of HCV resistance against PSI-7977
· Duration of PEG-IFN therapy [ Time Frame: SVR 12 and SVR 24 ] [ Designated as safety issue: No ]To explore the effects of the duration of PEG-IFN therapy on safety, tolerability, emergence of resistance, viral kinetics, SVR12, and SVR24
· Pharmacokinetics [ Time Frame: Ongoing ] [ Designated as safety issue: No ]To characterize the steady-state plasma pharmacokinetics of the PSI-6206 metabolite of PSI-7977
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