Hepatitis C, Chronic Clinical Trial
Official title:
Safety, Antiviral Activity, and Pharmacokinetics of Multiple Rising Oral Doses of BI 201335 NA in Treatment-naïve Patients With Chronic Hepatitis C Infection for 14 Days Monotherapy Followed by Combination With Pegylated Interferon and Ribavirin for an Additional 14 Days (Double-blind, Placebo Controlled), and in Treatment-experienced Patients With Chronic Hepatitis C Infection for 28 Days as Combination Therapy With Pegylated Interferon and Ribavirin (Open-label)
This study will investigate safety, antiviral activity, and pharmacokinetics of BI 201335 NA
in HCV genotype 1 infected patients treated for 14 days monotherapy followed by BI 201335 NA
combination therapy with PegIFN/RBV for an additional 14 days for treatment-naïve patients;
or for 28 days as BI 201335 NA combination therapy with PegIFN/RBV for treatment-experienced
patients.
A secondary objective is to investigate antiviral activity, potential drug-drug interactions
and safety of combination therapy of BI 201335 NA and PegIFN/RBV up to 28 days for
treatment-naïve patients.
n/a
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