This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
38
Quest Clinical Research
San Francisco, California, United States
the proportion of patients achieving sustained viral response (SVR)
Time frame: 12 weeks after the end of treatment
Proportion of patients with "virologic relapse" post-treatment, defined as confirmed and quantifiable (>LLOQ) serum HCV RNA in a patient who achieved non-detectable serum HCV RNA by the end of treatment
Time frame: up to 24 weeks post-treatment
Proportion of patients with confirmed viral breakthrough during study treatment
"Confirmed viral breakthrough" is defined as a \> 1 log increase in HCV RNA from post-Baseline nadir value or confirmed increase in HCV RNA ≥LLOQ if HCV RNA previously declined to \<LLOQ (detected or not detected), during the 12-week study treatment period
Time frame: up to 12 weeks of study treatment
Proportions of study participants who receive at least one dose of study drug and who prematurely discontinue study treatment, and proportions prematurely discontinuing treatment for clinical adverse events or laboratory abnormalities
Time frame: up to 12 weeks of study treatment
Proportions of study participants experiencing treatment-emergent adverse events (serious and non-serious) considered to be possibly or probably attributable to study treatment, overall and by body system
Time frame: up to 12 weeks of study treatment
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