Conditions: Hepatitis C, Chronic
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 25
Healthy volunteers: no

Brief summary:
The objective of this trial is to investigate tolerability, safety, pharmacokinetics and antiviral activity of BI 207127 NA in combination with BI 201335 NA and ribavirin for 8 weeks in Japanese treatment-naive patients with chronic GT-1 HCV infection.

Detailed description:

Arms:
arm 1: Patients receive BI 207127 NA,BI 201335 NA(high dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks arm 2: Patients receive BI 207127 NA,BI 201335 NA(low dose) and RBV for 8 wks followed by BI 201335 NA,PegIFN/RBV for 24 wks

Interventions: intervention 1: BI 207127 NA intervention 2: peginterferon intervention 3: Ribavirin intervention 4: Ribavirin intervention 5: BI 207127 NA intervention 6: BI 201335 NA intervention 7: BI 201335 NA intervention 8: peginterferon
Intervention descriptions: intervention 1: one fix dose intervention 2: per package insert intervention 3: per weight BID intervention 4: per weight BID intervention 5: one fix dose intervention 6: high dose intervention 7: low dose intervention 8: per package insert

Protocol document: