| |
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3, and GT1
|
| |
| |
This study is currently recruiting participants.
Verified July 2012 by Gilead Sciences
Purpose
To assess safety and tolerability of PSI-7977 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG-IFN) in subjects with hepatitis C (HCV) genotypes 1, 2 or 3.
Phase 2
Drug: PSI-7977 in combination with RBV
Drug: PSI-7977 in combination with RBV and PEG-IFN
Drug: PSI-7977 monotherapy
Drug: PSI-7977 in combination with 800 mg RBV
Drug: PSI-7977 in combination with GS-5885 and RBV
Primary Outcome Measures:
· Safety and Tolerability [ Time Frame: 8 or 12 weeks ] [ Designated as safety issue: Yes ]To assess the safety and tolerability of PSI-7977 400 mg for 8 or 12 weeks, administered with and without ribavirin and/or pegylated interferon alfa-2a (PEG-IFN) and with and without GS-5885 in subjects with HCV genotypes 1, 2 or 3
Experimental: Arm 12: PSI-7977, RBV, GS-5885
PSI-7977 400 mg QD and weight-based RBV and GS-5885 for 12 weeks in GT-1 null responders
Experimental: Arm 13: PSI-7977, RBV, GS-5885
PSI-7977 400 mg QD, weight-based RBV and GS-5885 for 12 weeks in GT-1 treatment naive subjects
Experimental: Arm 7: PSI-7977 with RBV
PSI-7977 400 mg QD with weight-based RBV for 12 weeks in GT-1 null responders
Experimental: Arm 8: PSI-7977 and RBV
PSI-7977 400 mg QD and weight-based RBV for 12 weeks in GT-1 treatment naive subjects
Experimental: Arm 9: PSI-7977 and RBV
PSI-7977 400 mg QD and weight-based RBV for 12 weeks in GT 2/3 treatment experienced subjects
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3L
Drug Interaction Study of PSI-7977 and Antiretroviral Therapy(ART) Combinations in Human Immunodeficiency Virus and Hepatitis C Virus (HIV/HCV) Co-infected Patients.
|
|
| |
| |
|
|
|
