| Primary | 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. | The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation. | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Triple TN Placebo | Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV). | | OG001 | Triple TN 120 mg | Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV. | | OG002 | Triple TN 240 mg | Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. | | OG003 | Triple TE 240 mg | Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. |
| | | Title | Denominators | Categories |
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| Primary | 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. | The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation. | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Triple TN Placebo | Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV). | | OG001 | Triple TN 120 mg | Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV. | | OG002 | Triple TN 240 mg | Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. | |
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| Secondary | 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)) | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo in TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | Week 4 Virological Response (W4VR) | Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ)) | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Rapid Virological Response (RVR) | Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4) | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Change From Baseline in HCV Viral Load | Change form baseline in HCV viral load (log10) after 4 weeks | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Mean | Standard Error | IU/mL | | baseline and week 4 | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | Day 28 Virologic Response | Number of patients with HCV viral load reduction >= 2 log10 at Week 4 | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Early Virological Response (EVR) | Number of patients with reduction >= 2 log10 in plasma HCV RNA level at Week 12 | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 12 Weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Complete Early Virological Response (cEVR) | Number of patients with plasma HCV RNA level BLD at Week 12 | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 12 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | End of Treatment Response (ETR) | Number of patients with plasma HCV RNA level BLD at week 48 | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 48 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Sustained Virologic Response (SVR) | Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion | The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication. | Posted | | Number | | participants | | 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | 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. | The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation. | Posted | | Number | | participant(s) | | 44 weeks | | | | ID | Title | Description |
|---|
| OG000 | SOC TN Placebo | Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV). | | OG001 | SOC TN 120 mg | Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV. | | OG002 | SOC TN 240 mg | Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. | | OG003 |
|
| Secondary | 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. | | Posted | | Number | | participant(s) | | 44 weeks | | | | ID | Title | Description |
|---|
| OG000 | SOC TN Placebo | Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV). | | OG001 | SOC TN 120 mg | Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV. | | OG002 | SOC TN 240 mg | Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. | | OG003 | SOC TE 240 mg | |
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| Secondary | 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. | | Posted | | Number | | participant(s) | | 44 weeks | | | | ID | Title | Description |
|---|
| OG000 | SOC TN Placebo | Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV). | | OG001 | SOC TN 120 mg | Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV. | | OG002 | SOC TN 240 mg | Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. | | OG003 | SOC TE 240 mg | Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. |
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| Secondary | AUCÏ„,1 for BI 201335 ZW | Area under the curve (AUC) concentration after the first dose of BI 201335 ZW | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | 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 | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | AUCÏ„,ss of BI 201335 ZW | AUC at steady state after 4 weeks combination of the last dose | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | Cmax,ss of BI 201335 ZW | Maximum concentration of BI 201335 ZW at steady state | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | AUCÏ„,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 | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
|
| Primary | 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. | The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation. | Posted | | Number | | participants | | 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | Triple TN Placebo | Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV). | | OG001 | Triple TN 120 mg | Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV. | | OG002 | Triple TN 240 mg | Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV. | | OG003 | Triple TE 240 mg | |
|
| Secondary | Cmax of RBV | Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
|
| Secondary | AUCÏ„,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 | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | | -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
|
| Secondary | 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 | The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
|
| Secondary | 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 | | Posted | | Median | Full Range | hour(s) | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | 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 | | Posted | | Median | Full Range | hour(s) | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | 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 | | Posted | | Median | Full Range | hour(s) | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | 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 | | Posted | | Median | Full Range | hour(s) | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | t1/2,ss for BI 201335 ZW | terminal half-life of the analyte in plasma at steady state (t1/2,ss) | | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour(s) | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Cmin,ss for BI 201335 ZW | Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Cmin,ss for RBV | Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
| |
| Secondary | Cavg for BI 201335 ZW | average plasma concentration (Cavg) of BI 201335 ZW | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
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| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | Cavg for RBV | average plasma concentration (Cavg) of RBV | | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
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| OG000 | Placebo TN | Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients | | OG001 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG003 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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| Secondary | 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 | | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/min | | 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dose | | | | ID | Title | Description |
|---|
| OG000 | BI 201335 NA Low TN | Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients | | OG001 | BI 201335 NA High TN | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients | | OG002 | BI 201335 NA High TE | Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients |
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