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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
22
ribavirin (RBV)
pegylated interferon (PegIFN) alfa-2a
pegylated interferon (PegIFN) alfa-2a
ribavirin (RBV)
Placebo
pegylated interferon (PegIFN) alfa-2a
ribavirin (RBV)
BI 201335 NA high
BI 201335 NA
placebo
BI 201335 NA high
1220.14.003 Boehringer Ingelheim Investigational Site
Kurashiki, Okayama, Japan
1220.14.001 Boehringer Ingelheim Investigational Site
Minato-ku, Tokyo, Japan
1220.14.002 Boehringer Ingelheim Investigational Site
Nishinomiya, Hyogo, Japan
Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Time frame: 4 weeks
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.
Time frame: 4 weeks
Assessment of Tolerability in Triple Combination Therapy
An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.
Time frame: 4 weeks
Week 2 Virological Response (W2VR)
Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))
Time frame: 2 weeks
Week 4 Virological Response (W4VR)
Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))
Time frame: 4 weeks
Rapid Virological Response (RVR)
Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)
Time frame: 4 weeks
Change From Baseline in HCV Viral Load
Change form baseline in HCV viral load (log10) after 4 weeks
Time frame: baseline and week 4
Day 28 Virologic Response
Number of patients with HCV viral load reduction \>= 2 log10 at Week 4
Time frame: 4 weeks
Early Virological Response (EVR)
Number of patients with reduction \>= 2 log10 in plasma HCV RNA level at Week 12
Time frame: 12 Weeks
Complete Early Virological Response (cEVR)
Number of patients with plasma HCV RNA level BLD at Week 12
Time frame: 12 weeks
End of Treatment Response (ETR)
Number of patients with plasma HCV RNA level BLD at week 48
Time frame: 48 weeks
Sustained Virologic Response (SVR)
Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion
Time frame: 72 weeks
Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Time frame: 44 weeks
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.
Time frame: 44 weeks
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.
Time frame: 44 weeks
AUCτ,1 for BI 201335 ZW
Area under the curve (AUC) concentration after the first dose of BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Cmax of BI 201335 ZW
Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
AUCτ,ss of BI 201335 ZW
AUC at steady state after 4 weeks combination of the last dose
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmax,ss of BI 201335 ZW
Maximum concentration of BI 201335 ZW at steady state
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
AUCτ,1 for Ribavirin (RBV)
Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
Cmax of RBV
Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose
AUCτ,ss of RBV
Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Cmax,ss of RBV
Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Time frame: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose
Tmax for BI 201335 ZW
Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Tmax for RBV
Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose
Tmax, ss for BI 201335 ZW
Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Tmax, ss for RBV
Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
t1/2,ss for BI 201335 ZW
terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmin,ss for BI 201335 ZW
Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cmin,ss for RBV
Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cavg for BI 201335 ZW
average plasma concentration (Cavg) of BI 201335 ZW
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
Cavg for RBV
average plasma concentration (Cavg) of RBV
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
CL/F,ss for BI 201335 ZW
apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration
Time frame: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose
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