Chronic Hepatitis C Infection Clinical Trial
Official title:
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with
weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no
PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4).
Part 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy)
for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks
(Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will
receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7).
Part 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced
participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV
for 12 weeks.
Part 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily
with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12
weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily,
ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive
participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks
(Arm 13).
Part 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500
mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive
participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based
RBV for 12 weeks (Arm 15).
Part 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for
12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2
or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV
genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks
(Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12
weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with
weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will
receive LDV/SOF FDC for 6 weeks (Arm 22).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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