Conditions: Hepatitis C Pharmacokinetics
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
The current Standard of Care (SOC) for chronic HCV infection, which is pegylated interferon-alfa as combination therapy with ribavirin for 24-48 weeks of treatment, is effective in only part of the patients and is often associated with severe adverse effects leading to discontinuation of treatment and dose modifications.

A number of compounds with direct activity are currently under clinical development, incl. BI 201335. BI 201335 works by preventing the Hepatitis C virus from replicating by binding to the HCV protease (enzyme). The main purpose of this clinical trial with BI 201335 is to see how well BI 201335 works and how safe BI 201335 is to use daily in combination with PegIFN and RBV in HCV infected patients

Detailed description:

Arms:
arm 1: patient to receive a capsule containing low dose of BI 201335 NA/Drug for treatment-naive (TN) patients arm 2: patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-naive (TN )patients arm 3: patient to receive a capsule containing high dose of BI 201335 NA/Drug for treatment-experienced (TE) patients arm 4: None

Interventions: intervention 1: ribavirin (RBV) intervention 2: pegylated interferon (PegIFN) alfa-2a intervention 3: pegylated interferon (PegIFN) alfa-2a intervention 4: ribavirin (RBV) intervention 5: BI 201335 NA low placebo intervention 6: pegylated interferon (PegIFN) alfa-2a intervention 7: ribavirin (RBV) intervention 8: BI 201335 NA high intervention 9: BI 201335 NA low intervention 10: BI 201335 NA high placebo intervention 11: BI 201335 NA high intervention 12: Placebo
Intervention descriptions: intervention 1: ribavirin (RBV) intervention 2: pegylated interferon (PegIFN) alfa-2a intervention 3: pegylated interferon (PegIFN) alfa-2a intervention 4: ribavirin (RBV) intervention 5: Placebo intervention 6: pegylated interferon (PegIFN) alfa-2a intervention 7: ribavirin (RBV) intervention 8: BI 201335 NA high intervention 9: BI 201335 NA intervention 10: placebo intervention 11: BI 201335 NA high intervention 12: None

Protocol document: