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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-008292-34 | EudraCT Number | EudraCT |
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The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 207127 low dose + SOC | Experimental | BI 207127 low dose tid + SOC |
|
| BI 207127 middle dose +SOC | Experimental | BI 207127 middle dose tid + SOC |
|
| BI 207127 high dose+SOC | Experimental | BI 207127 high dose tid +SOC |
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| Placebo + SOC | Placebo Comparator | Placebo tid +SOC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 207127 middle dose +SOC | Drug | BI 207127 middle dose tid + SOC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. | The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir. | Baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline | Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit. A negative value represents an increase in viral load, a positive value represents a decrease in viral load. | Baseline and days 1, 2, 4, 8, 15, 22 and 28 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1241.7.3307A CHU de Grenoble | Grenoble Cédex 9 | France | ||||
| 1241.7.3303A Hôpital Claude Huriez |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22414766 | Derived | Larrey D, Lohse AW, de Ledinghen V, Trepo C, Gerlach T, Zarski JP, Tran A, Mathurin P, Thimme R, Arasteh K, Trautwein C, Cerny A, Dikopoulos N, Schuchmann M, Heim MH, Gerken G, Stern JO, Wu K, Abdallah N, Girlich B, Scherer J, Berger F, Marquis M, Kukolj G, Bocher W, Steffgen J. Rapid and strong antiviral activity of the non-nucleosidic NS5B polymerase inhibitor BI 207127 in combination with peginterferon alfa 2a and ribavirin. J Hepatol. 2012 Jul;57(1):39-46. doi: 10.1016/j.jhep.2012.02.015. Epub 2012 Mar 10. |
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75 patients were screened, however only 57 patients were randomised.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Naive (TN): Placebo | Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| FG001 | Treatment Naive (TN): BI 207127 400 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| BI 207127 high dose+SOC |
| Drug |
BI 207127 high dose tid +SOC |
|
| Placebo + SOC | Drug | Placebo tid +SOC |
|
| BI 207127 low dose + SOC | Drug | BI 207127 low dose tid + SOC |
|
| Viral Load at Each Visit up to Day 28 | Viral load (VL) (original values) at each visit up to day 28. | Baseline and days 8, 15, 22 and 28 |
| Number of Participants With Virologic Response at Day 28 | Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28 | day 28 |
| Number of Participants With Rapid Virological Response | Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28. | 4 weeks |
| Number of Participants With Early Virological Response | Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84) | Baseline and week 12 |
| Number of Participants With End of Treatment Response | Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment. | Week 12 |
| Number of Participants With Sustained Virological Response | Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC). | Until end of treatment, up to 570 days |
| Plasma Concentration Time Profiles of BI 207127 | Plasma concentration time profiles of BI 207127 | 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration |
| Plasma Concentration Time Profiles of CD 6168 | Plasma concentration time profiles of CD 6168 | 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration |
| Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) | Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168 | 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) | tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state). | 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) | Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168 | 30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28 |
| Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 | Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below. | 5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27 |
| C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h). | 654 hours after drug administration on day 28 |
| AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax. | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG | Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events. | From the start of the study to Day 30 (2 days after last dose) |
| Number of Participants With Discontinuations Due to AEs | Number of participants with adverse events (AEs) leading to discontinuation of trial drug | 4 weeks |
| Lille |
| France |
| 1241.7.3302A Hopital de l'Hotel Dieu | Lyon | France |
| 1241.7.3301A Hôpital Saint Eloi | Montpellier | France |
| 1241.7.3305A HOP Archet 2 | Nice | France |
| 1241.7.3306A Hôpital Haut-Lévêque | Pessac | France |
| 1241.7.3304A HOP de Brabois | Vandœuvre-lès-Nancy | France |
| 1241.7.49010 Boehringer Ingelheim Investigational Site | Aachen | Germany |
| 1241.7.49012 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1241.7.49004 Boehringer Ingelheim Investigational Site | Essen | Germany |
| 1241.7.49011 Boehringer Ingelheim Investigational Site | Freiburg im Breisgau | Germany |
| 1241.7.49001 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1241.7.49013 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1241.7.49009 Boehringer Ingelheim Investigational Site | Regensburg | Germany |
| 1241.7.49002 Boehringer Ingelheim Investigational Site | Ulm | Germany |
| 1241.7.41003 Boehringer Ingelheim Investigational Site | Basel | Switzerland |
| 1241.7.41004 Boehringer Ingelheim Investigational Site | Lugano | Switzerland |
| 1241.7.41001 Boehringer Ingelheim Investigational Site | Sankt Gallen | Switzerland |
TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| FG002 | Treatment Naive (TN): BI 207127 600 mg | TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| FG003 | Treatment Naive (TN): BI 207127 800 mg | TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| FG004 | Treatment Experienced (TE): BI 207127 400 mg | Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| FG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| FG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days |
| COMPLETED |
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| NOT COMPLETED |
|
|
Treated Set (TS): All patients who received at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days |
| BG001 | Treatment Naive (TN): BI 207127 400 mg | TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| BG002 | Treatment Naive (TN): BI 207127 600 mg | TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| BG003 | Treatment Naive (TN): BI 207127 800 mg | TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| BG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| BG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| BG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| BG007 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Virologic Response Defined as >= 3 Log Drop in Viral Load From Baseline at Day 28 With no Evidence of Virologic Rebound During These 28 Days. Virologic Rebound is Defined as >= 1 Log Increase in Viral Load From Nadir. | The primary efficacy endpoint is the number of participants with virologic response defined as >= 3 log drop in viral load from baseline at day 28 with no evidence of virologic rebound during these 28 days. Virologic rebound is defined as >= 1 log increase in viral load from nadir. | Full Analysis Set (FAS): The subset of patients in the treated set (TS) that had at least one measurement of efficacy. | Posted | Number | Participants | Baseline and 4 weeks |
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| Secondary | Viral Load (Log10) at Each Visit up to Day 28, Change From Baseline | Reductions of viral load (Log10) at each visit up to day 28, change from baseline. Change from baseline was calculated as the value at baseline minus the value at each later visit. A negative value represents an increase in viral load, a positive value represents a decrease in viral load. | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available viral load data at baseline and day 28. | Posted | Median | Full Range | IU/mL | Baseline and days 1, 2, 4, 8, 15, 22 and 28 |
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| Secondary | Viral Load at Each Visit up to Day 28 | Viral load (VL) (original values) at each visit up to day 28. | Pharmacodynamic (PD) set which included patients in the treated set but excluded VL values after recorded treatment stop time and values after subjects took wrong or additional doses of treatment. Also one patient was excluded from all descriptive PD summaries due to a protocol violation and another excluded as they did not have a predose VL value. | Posted | Median | Full Range | IU/mL | Baseline and days 8, 15, 22 and 28 |
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| Secondary | Number of Participants With Virologic Response at Day 28 | Number of participants with virologic response at day 28, defined as achieving viral load below the limit of quantification (BLQ), <10 IU/mL, at day 28 | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | Participants | day 28 |
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| Secondary | Number of Participants With Rapid Virological Response | Number of participants with rapid virological response - defined as serum Hepatitis C virus (HCV) RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/High Pure System (HPS) for extraction assay (10 IU/mL) on Day 28. | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | Participants | 4 weeks |
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| Secondary | Number of Participants With Early Virological Response | Number of participants with early virological response (EVR) defined as at least 2log10 reduction in HCV Ribonucleic acid (RNA) from baseline at Week 12. Number of responders* - Response = At least a 2 log10 reduction in viral load from baseline at Week 12 (Day 84) | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | Participants | Baseline and week 12 |
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| Secondary | Number of Participants With End of Treatment Response | Number of participants with end of treatment response (ETR) - defined as serum HCV RNA level below the limit of detection (BLD) of the Roche COBAS Taqman HCV/HPS assay (10 IU/mL) at end of treatment (including 5-day washout). Number of responders* - Response = Viral load below the limit of detection at end of all treatment. | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | Participants | Week 12 |
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| Secondary | Number of Participants With Sustained Virological Response | Number of participants with sustained virological response. Sustained virological response was defined as serum HCV RNA below the limit of detection (<10 IU/mL) at least 85 days after stopping standard care (SOC). | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | Participants | Until end of treatment, up to 570 days |
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| Secondary | Plasma Concentration Time Profiles of BI 207127 | Plasma concentration time profiles of BI 207127 | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration |
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| Secondary | Plasma Concentration Time Profiles of CD 6168 | Plasma concentration time profiles of CD 6168 | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 0.5 hours (h), 3h, 8h, 15h, 23.917h, 503.917h, 649h, 652h, 656h and 672h after drug administration |
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| Secondary | Cmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) | Maximum measured concentration of the analyte in plasma (Cmax) after first dose on day 1 (Cmax) and after last dose (steady state) on day 28 (Cmax,ss) of BI 207127 and CD 6168 | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
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| Secondary | Tmax of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) | tmax [h] Time from (last) dosing to the maximum measured concentration of the analyte in plasma after first dose on day 1 and after last dose on day 28 (steady state). | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 5 min before drug admin and 30min, 1 hour (h), 2h, 3h, 4h, 5h 55min, 8h, 10h, 11h 55min and 15h after drug administration on day 1: 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
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| Secondary | AUC0-6 of BI 207127 and CD 6168 in Plasma After First Dose and After Last Dose (Steady State) | Area under the concentration-time curve of the analyte in plasma (AUC) after first dose on day 1 (AUC0-6) and after last dose on day 28 (AUC0-6,ss) of BI 207127 and CD 6168 | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 30min, 1 hour (h), 2h, 3h, 4h and 5h 55min after drug administration on day 1: 30min, 1h, 2h, 3h, 4h and 6h after admin on day 28 |
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| Secondary | Cpre Pharmacokinetic Parameter of BI 207127 and CD 6168 | Cpre,N [ng/mL] - Predose concentration of the analyte in plasma immediately before administration of the Nth dose after N-1 doses were administered for BI 207127 and CD 6168. Descriptive statistics were calculated only if at least 2/3 plasma concentrations were available. All values for Cpre,1 were not available, therefore no results are presented below. | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 5 minutes before drug administration on days 1, 2, 4, 8, 15, 22 and 27 |
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| Secondary | C6,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | C6,ss Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. C6,ss is the concentration 6 hours after dosing at steady-state (reported as 654 h). | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | 654 hours after drug administration on day 28 |
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| Secondary | AUC0-infinity,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Area under the concentration time curve of the analyte in plasma over the time interval of 0 to infinity at steady state (AUC0-infinity,ss): Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State (SS) After the Last Dose | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
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| Secondary | λz Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Terminal rate constant in plasma (λz): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | 1/h | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
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| Secondary | t1/2,ss and MRTpo,ss Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Terminal half-life of the analyte in plasma at steady state (t1/2,ss) and mean residence time of the analyte in the body at steady state after oral administration (MRTpo,ss): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | hour | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
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| Secondary | RA,Cmax Pharmacokinetic Parameters of BI 207127 and CD 6168 at Steady State After the Last Dose | Accumulation ratio of maximum measured concentration of the analyte in plasma (RA,Cmax): Pharmacokinetic parameters of BI 207127 and CD 6168 at steady state after the last dose. Ratio was calculated as Cmax,ss divided by Cmax. | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy and available endpoint data at day 28. One patient in the TE: BI 207127 400 mg group was excluded from the analysis due to a protocol violation. | Posted | Geometric Mean | Geometric Coefficient of Variation | ratio | 5 min before drug admin and 30min, 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h and 48h after admin on day 28 |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinical Relevant Abnormalities for Vital Signs, Body Temperature, Physical Examination, Blood Chemistry, Haematology, Coagulation, Urinalysis and ECG | Number of participants with clinically relevant abnormalities for vital signs, blood chemistry, body temperature, physical examination, haematology, coagulation, urinalysis and electrocardiography (ECG). New abnormal findings or worsening of baseline conditions were reported as adverse events. | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | participants | From the start of the study to Day 30 (2 days after last dose) |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Discontinuations Due to AEs | Number of participants with adverse events (AEs) leading to discontinuation of trial drug | Full Analysis Set (FAS): The subset of patients in the TS that had at least one measurement of efficacy. | Posted | Number | participants | 4 weeks |
|
From drug administration until 2 days after the end of treatment, up to 570 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days | 0 | 8 | 7 | 8 | ||
| EG001 | BI 207127 400 mg | patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days | 2 | 16 | 16 | 16 | ||
| EG002 | BI 207127 600 mg | patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days | 0 | 16 | 16 | 16 | ||
| EG003 | BI 207127 800 mg | patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days | 1 | 17 | 17 | 17 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Umbilical hernia | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Abnormal sensation in eye | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Myopia | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Frequent bowel movements | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal hypermotility | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Gastrointestinal pain | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Gingivitis | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Lip dry | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Feeling cold | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Irritability | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Malaise | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Pain | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Jaundice cholestatic | Hepatobiliary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Bronchitis viral | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Herpes virus infection | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MEDDRA 15.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MEDDRA 15.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MEDDRA 15.0 | Systematic Assessment |
| |
| General physical condition normal | Investigations | MEDDRA 15.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 15.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hyperphagia | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Growing pains | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Muscle twitching | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Burning sensation | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Cognitive disorder | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dysaesthesia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Formication | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Micturition urgency | Renal and urinary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Breast discomfort | Reproductive system and breast disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Excessive granulation tissue | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Night sweats | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MEDDRA 15.0 | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MEDDRA 15.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BIs intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000592437 | deleobuvir |
Not provided
Not provided
Not provided
| Male |
|
TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG004 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG006 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 |
| Treatment Experienced (TE): BI 207127 400 mg |
TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| Treatment Experienced (TE): BI 207127 400 mg |
TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| Treatment Experienced (TE): BI 207127 400 mg |
TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| OG003 | Treatment Experienced (TE): BI 207127 400 mg | TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG004 | Treatment Experienced (TE): BI 207127 600 mg | TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
| OG005 | Treatment Experienced (TE): BI 207127 800 mg | TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days |
|
|
| Units | Counts |
|---|
| Participants |
|
|