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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003538-11 | EudraCT Number | EudraCT |
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The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI 201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed in treatment-naïve (TN) and treatment experienced (TE) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 240 mg QD TN | Experimental | 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients |
|
| 240 mg QD / LI-TN | Experimental | 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients |
|
| Placebo | Placebo Comparator | Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients |
|
| 120 mg QD / LI-TN | Experimental | 120 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 201335 NA 240 mg QD / LI | Drug | 240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo | An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD). This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48. The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'. | Week 28 |
| Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy | Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection. The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24. Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved. | Day 155 after the end of all treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Virological Response at Week 2 | Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable) | Week 2 |
| Virological Response at Week 4 |
Not provided
Inclusion criteria:
chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL >=100,000 IU/mL Liver biopsy within 2 years prior to study enrolment showing necroinflammatory activity or presence of fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65 years Females and males with adequate contraception
Exclusion criteria:
Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous treatment with protease inhibitor Evidence of liver disease due to causes other than chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or history of decompensated liver disease Active or suspected malignancy or history of malignancy within the last 5 years History of alcohol or drug abuse within the past 12 months. Usage of any investigational drug within 30 days prior to enrolment, or 5 half-lives, whichever is longer Known hypersensitivity to any ingredient of the study drugs Condition that is defined as one which in the opinion of the investigator may put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study Alpha-fetoprotein value > 100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no evidence of liver cancer in two congruent imaging studies Total bilirubin > 1.5x ULN wiht ratio of direct/indirect >1. ALT or AST levels > 5x ULN INR prolonged to >1.5x ULN Exclusion criteria related to PegIFN and/or RBV restrictions.
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.5.0001 Boehringer Ingelheim Investigational Site | San Francisco | California | United States | |||
| 1220.5.0008 Boehringer Ingelheim Investigational Site |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo-TN | Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV (Pegylated interferon α-2a (Pegasys®)/ Ribavirin (Copegus®)): PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| FG001 | 120 mg QD / LI-TN |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 240 mg QD TE | Experimental | 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients |
|
| 240 mg QD / LI-TE | Experimental | 240 mg BI 201335 NA (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 (Faldaprevir) three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients |
|
| 240 mg BID / LI-TE | Experimental | 240mg BI 201335 NA (Faldaprevir) twice daily combined with PegIFN/RBV for 24 or 48 weeks, with 3-day lead-in phase of PegIFN/RBV, in treatment-experienced patients |
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks |
|
| BI 201335 NA 120mg QD / LI | Drug | 120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks |
|
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks |
|
| BI 201335 NA 240 mg QD | Drug | 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks |
|
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks |
|
| BI 201335 NA 240 mg QD | Drug | 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks |
|
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks |
|
| BI 201335 NA 240 mg BID | Drug | 240mg BI 201335 NA (Faldaprevir) twice, 24 weeks |
|
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks |
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks |
|
| BI 201335 NA 240 mg QD | Drug | 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks |
|
|
| PegIFN/RBV | Drug | PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks |
|
| Placebo | Drug | Placebo |
|
Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable)
| Week 4 |
| Early Virological Response (EVR) | Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12 | Baseline and Week 12 |
| Extended Rapid Virological Response (eRVR) | Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12 | Week 4 and Week 12 |
| Complete Early Virological Response (cEVR) | Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12 | Week 12 |
| End of Treatment Response at Week 24 | End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24. | Week 24 |
| End of Treatment Response at End of All Therapy | End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48 | Week 24 or Week 48 |
| Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy | Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60 | Week 36 or Week 60 |
| Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection | Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD) | On or after day 155 post end of all treatment |
| Time to Loss of Virological Response | Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero. Time is expressed in Median number of days. | Week 24 |
| Virological Rebound | Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection. Note that this is numerical rebound, not requiring confirmation with a re-measurement. | Week 24 or Week 48 |
| Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing) | Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout. | Up to Week 24 |
| Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing) | Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout. | Week 24 through Week 48 |
| Relapse | Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection. Patients could experience relapse at any point post-treatment. | post-End of treatment (i.e. post 48 weeks) |
| Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure | Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo. | Baseline and Week 24 |
| Change From Baseline to Week 24 in Pulse Rate | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Baseline and Week 24 |
| Change From Baseline to Week 24 in Weight of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Baseline and Week 24 |
| Global Assessment of Tolerability | The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. | Week 24 |
| Change From Baseline to Week 24 in Haemoglobin of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Baseline and Week 24 |
| Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin | Number of patients with normal or high baseline moved to low . | Baseline and Week 24 |
| Change From Baseline to Week 24 in Absolute Neutrophils of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Baseline and Week 24 |
| Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils | Number of patients with normal or high baseline moved to low . | Baseline and Week 24 |
| Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients | Baseline is defined as the last value before the drug administration of BI 201335 or placebo. | Baseline and Week 24 |
| Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT | Number of patients with normal or low baseline moved to high . | Baseline and Week 24 |
| Change From Baseline to Week 24 in Total Bilirubin of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Baseline and Week 24 |
| Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin | Number of patients with normal or low baseline moved to high . | Baseline and Week 24 |
| Trough Concentration (Cpre,ss) of Faldaprevir at Steady State | C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose. | Week 8, week 10, week 12, week 24 |
| Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV) | C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose. | Week 8, week 10, week 12, week 24 |
| Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV) | C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose. | Week 8, week 10, week 12, week 24 |
| Trough Concentration (Cpre,ss) of PegIFN at Steady State | C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose. | Week 8, week 10, week 12, week 24 |
| San Francisco |
| California |
| United States |
| 1220.5.0005 Boehringer Ingelheim Investigational Site | Chicago | Illinois | United States |
| 1220.5.0006 Boehringer Ingelheim Investigational Site | Lutherville | Maryland | United States |
| 1220.5.0002 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 1220.5.0003 Boehringer Ingelheim Investigational Site | New York | New York | United States |
| 1220.5.0007 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania | United States |
| 1220.5.0010 Boehringer Ingelheim Investigational Site | Germantown | Tennessee | United States |
| 1220.5.0009 Boehringer Ingelheim Investigational Site | Nashville | Tennessee | United States |
| 1220.5.0004 Boehringer Ingelheim Investigational Site | Austin | Texas | United States |
| 1220.5.5401 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1220.5.5403 Boehringer Ingelheim Investigational Site | Capital Federal | Argentina |
| 1220.5.5405 Boehringer Ingelheim Investigational Site | Derqui, Pilar | Argentina |
| 1220.5.5402 Boehringer Ingelheim Investigational Site | Rosario | Argentina |
| 1220.5.5406 Boehringer Ingelheim Investigational Site | Rosario | Argentina |
| 1220.5.6110 Boehringer Ingelheim Investigational Site | Camperdown | New South Wales | Australia |
| 1220.5.6109 Boehringer Ingelheim Investigational Site | Kogarah | New South Wales | Australia |
| 1220.5.6105 Boehringer Ingelheim Investigational Site | Randwick | New South Wales | Australia |
| 1220.5.6101 Boehringer Ingelheim Investigational Site | Westmead | New South Wales | Australia |
| 1220.5.6103 Boehringer Ingelheim Investigational Site | Herston | Queensland | Australia |
| 1220.5.6104 Boehringer Ingelheim Investigational Site | Woolloongabba | Queensland | Australia |
| 1220.5.6102 Boehringer Ingelheim Investigational Site | Clayton | Victoria | Australia |
| 1220.5.6107 Boehringer Ingelheim Investigational Site | Fitzroy | Victoria | Australia |
| 1220.5.6108 Boehringer Ingelheim Investigational Site | Parkville | Victoria | Australia |
| 1220.5.4303 Boehringer Ingelheim Investigational Site | Linz | Austria |
| 1220.5.4301 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1220.5.4302 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 1220.5.1003 Boehringer Ingelheim Investigational Site | Edmonton | Alberta | Canada |
| 1220.5.1007 Boehringer Ingelheim Investigational Site | Vancouver | British Columbia | Canada |
| 1220.5.1006 Boehringer Ingelheim Investigational Site | Hamilton | Ontario | Canada |
| 1220.5.1001 Boehringer Ingelheim Investigational Site | Ottawa | Ontario | Canada |
| 1220.5.1002 Boehringer Ingelheim Investigational Site | Toronto | Ontario | Canada |
| 1220.5.1004 Boehringer Ingelheim Investigational Site | Montreal | Quebec | Canada |
| 1220.5.4202 Boehringer Ingelheim Investigational Site | Mělník | Czechia |
| 1220.5.4203 Boehringer Ingelheim Investigational Site | Opava | Czechia |
| 1220.5.3301A Boehringer Ingelheim Investigational Site | Clichy | France |
| 1220.5.3307A Boehringer Ingelheim Investigational Site | Créteil | France |
| 1220.5.3309A Boehringer Ingelheim Investigational Site | Lyon | France |
| 1220.5.3304A Boehringer Ingelheim Investigational Site | Marseille | France |
| 1220.5.3306A Boehringer Ingelheim Investigational Site | Montpellier | France |
| 1220.5.3302A Boehringer Ingelheim Investigational Site | Paris | France |
| 1220.5.3303A Boehringer Ingelheim Investigational Site | Paris | France |
| 1220.5.3308A Boehringer Ingelheim Investigational Site | Paris | France |
| 1220.5.3305A Boehringer Ingelheim Investigational Site | Vandœuvre-lès-Nancy | France |
| 1220.5.4902 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1220.5.4903 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1220.5.4917 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 1220.5.4914 Boehringer Ingelheim Investigational Site | Bochum | Germany |
| 1220.5.4913 Boehringer Ingelheim Investigational Site | Bonn | Germany |
| 1220.5.4915 Boehringer Ingelheim Investigational Site | Dortmund | Germany |
| 1220.5.4905 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1220.5.4912 Boehringer Ingelheim Investigational Site | Düsseldorf | Germany |
| 1220.5.4906 Boehringer Ingelheim Investigational Site | Frankfurt am Main | Germany |
| 1220.5.4908 Boehringer Ingelheim Investigational Site | Hamburg | Germany |
| 1220.5.4904 Boehringer Ingelheim Investigational Site | Hanover | Germany |
| 1220.5.4910 Boehringer Ingelheim Investigational Site | Leipzig | Germany |
| 1220.5.4909 Boehringer Ingelheim Investigational Site | Mainz | Germany |
| 1220.5.4907 Boehringer Ingelheim Investigational Site | Tübingen | Germany |
| 1220.5.3101 Boehringer Ingelheim Investigational Site | Amsterdam | Netherlands |
| 1220.5.3102 Boehringer Ingelheim Investigational Site | Leiden | Netherlands |
| 1220.5.3501 Boehringer Ingelheim Investigational Site | Coimbra | Portugal |
| 1220.5.3504 Boehringer Ingelheim Investigational Site | Coimbra | Portugal |
| 1220.5.3502 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1220.5.3503 Boehringer Ingelheim Investigational Site | Lisbon | Portugal |
| 1220.5.3506 Boehringer Ingelheim Investigational Site | Porto | Portugal |
| 1220.5.3507 Boehringer Ingelheim Investigational Site | Porto | Portugal |
| 1220.5.4001 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1220.5.4002 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1220.5.4003 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1220.5.4004 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 1220.5.8210 Boehringer Ingelheim Investigational Site | Busan | South Korea |
| 1220.5.8205 Boehringer Ingelheim Investigational Site | Daegu | South Korea |
| 1220.5.8201 Boehringer Ingelheim Investigational Site | Pusan | South Korea |
| 1220.5.8202 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1220.5.8206 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1220.5.8207 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1220.5.8208 Boehringer Ingelheim Investigational Site | Seoul | South Korea |
| 1220.5.8204 Boehringer Ingelheim Investigational Site | Seoungnam | South Korea |
| 1220.5.8203 Boehringer Ingelheim Investigational Site | Sungnam | South Korea |
| 1220.5.8209 Boehringer Ingelheim Investigational Site | Suwon | South Korea |
| 1220.5.8211 Boehringer Ingelheim Investigational Site | Yangsan | South Korea |
| 1220.5.3402 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1220.5.3405 Boehringer Ingelheim Investigational Site | Barcelona | Spain |
| 1220.5.3401 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1220.5.3403 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1220.5.3404 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1220.5.3406 Boehringer Ingelheim Investigational Site | Madrid | Spain |
| 1220.5.4104 Boehringer Ingelheim Investigational Site | Bern | Switzerland |
| 1220.5.4102 Boehringer Ingelheim Investigational Site | La Chaux-de-Fonds | Switzerland |
| 1220.5.4103 Boehringer Ingelheim Investigational Site | Lugano | Switzerland |
| 1220.5.4101 Boehringer Ingelheim Investigational Site | Zurich | Switzerland |
| 1220.5.4106 Boehringer Ingelheim Investigational Site | Zurich | Switzerland |
| 1220.5.4405 Boehringer Ingelheim Investigational Site | Bristol | United Kingdom |
| 1220.5.4401 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1220.5.4402 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1220.5.4406 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1220.5.4409 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1220.5.4410 Boehringer Ingelheim Investigational Site | London | United Kingdom |
| 1220.5.4408 Boehringer Ingelheim Investigational Site | Nottingham | United Kingdom |
| 1220.5.4403 Boehringer Ingelheim Investigational Site | Southampton | United Kingdom |
120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| FG002 | 240 mg QD / LI-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| FG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| FG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| FG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| FG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Treated set: The treated set (TS) included all patients who were dispensed study medication and were documented to have taken at least one dose of investigational treatment, whether randomised or not
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo-TN | Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| BG001 | 120 mg QD / LI-TN | 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| BG002 | 240 mg QD / LI-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| BG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| BG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| BG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| BG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| 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 | Virological Response 4 Weeks After the End of Treatment With BI 201335 or Placebo | An achieved virological response is defined as the plasma Hepatitis C Virus RiboNucleic Acid (HCV RNA) level below the lower limit of detection (BLD). This data was only collected for patients, who stopped trial participation at Week 24 and did not continue with PegIFN/RBV until Week 48. The lower limit of quantification (BLQ) of this assay was 25 IU/mL and the lower limit of detection (BLD) was 10 IU/mL at the time of the protocol finalisation. During the course of the trial, the manufacturer defined BLD as '< 25 IU/mL, not detectable' and BLQ as '< 25 IU/mL, detectable'. | Per protocol set (PPS): PPS was subset of full analysis set,consisted of all patients without important protocol deviations . FAS was composed of all randomised patients who took at least 1 dose of study medication. For this outcome, only patients who were not on PegIFN/RBV treatment 4 weeks after stop of BI 201335 or Placebo were investigated. | Posted | Number | percentage of patients | Week 28 |
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| Primary | Sustained Virological Response 24 Weeks (SVR24) After Completion of All Therapy | Virological (VL) response was defined as the plasma HCV RNA level below the lower limit of detection. The first VL measurement that occurred in the time window ≥ Day 155 (from End Of Treatment on) was selected for the determination of SVR24. Therefore, patients with virological load BLD 24 weeks after completion of therapy, who had a rebound after this time point (outside the defined time window of 155 days after end of all treatments) were identified as SVR24 achieved. | Per protocol set | Posted | Number | 95% Confidence Interval | percentage of patients | Day 155 after the end of all treatment |
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| Secondary | Virological Response at Week 2 | Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 2 (< 25 IU/ml, detectable or undetectable) | Per protocol set | Posted | Number | percentage of patients | Week 2 |
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| Secondary | Virological Response at Week 4 | Viral load (plasma HCV RNA level) below the lower limit of quantification at Week 4 (< 25 IU/ml, detectable or undetectable) | Per protocol set | Posted | Number | percentage of patients | Week 4 |
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| Secondary | Early Virological Response (EVR) | Early Virological Response (EVR) is defined as ≥ 2 log 10 reduction in plasma HCV RNA level from baseline at Week 12 | Per protocol set | Posted | Number | percentage of patients | Baseline and Week 12 |
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| Secondary | Extended Rapid Virological Response (eRVR) | Extended Rapid Virological Response (eRVR) is defined as plasma HCV RNA levels below the lower limit of quantification at Week 4 and below the lower limit of detection at Week 12 | Per protocol set | Posted | Number | percentage of patients | Week 4 and Week 12 |
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| Secondary | Complete Early Virological Response (cEVR) | Complete Early Virological Response (cEVR) is defined as plasma HCV RNA level below the lower limit of detection at Week 12 | Per protocol set | Posted | Number | percentage of patients | Week 12 |
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| Secondary | End of Treatment Response at Week 24 | End of Treatment Response of BI 201335 or placebo (ETR BI 201335/placebo ) is defined as plasma HCV RNA level below the lower limit of detection at Week 24. | Per protocol set | Posted | Number | percentage of patients | Week 24 |
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| Secondary | End of Treatment Response at End of All Therapy | End of Treatment Response (ETR) is defined as plasma HCV RNA level below the lower limit of detection at end of all therapy, i.e. at Week 24 or Week 48 | Per protocol set | Posted | Number | percentage of patients | Week 24 or Week 48 |
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| Secondary | Sustained Virological Response 12 Weeks (SVR12) After Completion of All Therapy | Sustained Virological Response 12 Weeks (SVR12) after completion of all therapy is defined as plasma HCV RNA level below the lower limit of detection at 12 weeks after completion of all therapy, i.e. at Week 36 or 60 | Per protocol set | Posted | Number | percentage of patients | Week 36 or Week 60 |
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| Secondary | Time to Reach a Plasma HCV RNA Level Below the Lower Limit of Detection | Summary of time (i.e Median number of days) to reach a plasma HCV RNA level below limit of detection (BLD) | Per protocol set | Posted | Median | Full Range | Days | On or after day 155 post end of all treatment |
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| Secondary | Time to Loss of Virological Response | Time to loss of virological response, defined as the last value below the lower limit of detection in a patient who subsequently had 2 consecutive plasma HCV RNA level measurements ≥100 IU/mL. Patients that did not achieve suppression of plasma HCV RNA levels below the lower limit of detection until Week 24 were defined as having a time to failure of zero. Time is expressed in Median number of days. | Per protocol set | Posted | Median | 95% Confidence Interval | Number of days | Week 24 |
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| Secondary | Virological Rebound | Virological rebound is defined as increase of ≥ 1 log 10 in plasma HCV RNA level from a quantifiable nadir, or to ≥ 250 IU/mL after previous nadir < 25 IU/mL (detectable), or to ≥ 100 IU/mL after a previous viral load below the lower limit of detection. Note that this is numerical rebound, not requiring confirmation with a re-measurement. | Per protocol set | Posted | Number | percentage of patients | Week 24 or Week 48 |
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| Secondary | Breakthrough on BI 201335/Placebo (Rebound While All 3 Treatments Were Still Ongoing) | Number of patients with Unconfirmed rebound ( ≥ 1log10 increase in HCV mRNA) while on BI201335/placebo + 5 days washout. | Per protocol set | Posted | Number | percentage of patients | Up to Week 24 |
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| Secondary | Breakthrough on PegIFN/RBV (Rebound While Only PegIFN/RBV Treatment Alone Was Still Ongoing) | Number of patients with Unconfirmed rebound (≥ 1log10 increase in HCV mRNA) while on PegIFN/RBV treatment + 5 days washout. | Per protocol set | Posted | Number | percentage of patients | Week 24 through Week 48 |
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| Secondary | Relapse | Relapse was rebound after the viral load at end of all treatment had been below the lower limit of detection, or, if the value at end of all treatment was missing, after both the last value before End of Treatment (EOT) and the first value after End of Treatment were below the lower limit of detection. Patients could experience relapse at any point post-treatment. | Per protocol set | Posted | Number | percentage of patients | post-End of treatment (i.e. post 48 weeks) |
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| Secondary | Change From Baseline to Week 24 in Diastolic Blood Pressure and Systolic Blood Pressure | Baseline is defined as the last value before the initial drug administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in Systolic blood pressure and Diastolic blood pressure at Week 24) | Posted | Mean | Standard Deviation | mmHg | Baseline and Week 24 |
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| Secondary | Change From Baseline to Week 24 in Pulse Rate | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in Pulse rate at Week 24) | Posted | Mean | Standard Deviation | bpm | Baseline and Week 24 |
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| Secondary | Change From Baseline to Week 24 in Weight of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in Weight at Week 24) | Posted | Mean | Standard Deviation | kg | Baseline and Week 24 |
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| Secondary | Global Assessment of Tolerability | The investigator was to assess the tolerability of trial medication based on adverse events (AEs) and the laboratory evaluation. Tolerability was assessed by the investigator according to the categories 'good', 'satisfactory', 'not satisfactory', and 'bad'. | Per protocol set | Posted | Number | percentage of patients | Week 24 |
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| Secondary | Change From Baseline to Week 24 in Haemoglobin of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in Haemoglobin at Week 24) | Posted | Mean | Standard Deviation | g/dL | Baseline and Week 24 |
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| Secondary | Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Haemoglobin | Number of patients with normal or high baseline moved to low . | Treated Set (for patients with normal or high baseline Haemoglobin) | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Change From Baseline to Week 24 in Absolute Neutrophils of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in Absolute Neutrophils at Week 24) | Posted | Mean | Standard Deviation | GI/L | Baseline and Week 24 |
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| Secondary | Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Absolute Neutrophils | Number of patients with normal or high baseline moved to low . | Treated Set (for patients with normal or high baseline Absolute Neutrophils) | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Change From Baseline to Week 24 in ALT/GPT,SGPT of the Patients | Baseline is defined as the last value before the drug administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in ALT/GPT,SGPT at Week 24) | Posted | Mean | Standard Deviation | U/L | Baseline and Week 24 |
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| Secondary | Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter ALT/GPT,SGPT | Number of patients with normal or low baseline moved to high . | Treated Set (for patients with normal or low baseline ALT/GPT,SGPT) | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Change From Baseline to Week 24 in Total Bilirubin of the Patients | Baseline is defined as the last value before the administration of BI 201335 or placebo. | Treated Set (for patients with change from baseline in Total Bilirubin at Week 24) | Posted | Mean | Standard Deviation | mg/dL | Baseline and Week 24 |
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| Secondary | Number of Patients [N(%)] With Transitions Relative to Reference Range for Laboratory Parameter Total Bilirubin | Number of patients with normal or low baseline moved to high . | Treated Set (for patients with normal or low baseline Total Bilirubin) | Posted | Number | percentage of patients | Baseline and Week 24 |
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| Secondary | Trough Concentration (Cpre,ss) of Faldaprevir at Steady State | C(pre,ss) is defined as pre-dose (trough) concentration of Faldaprevir in plasma at steady state immediately before administration of the next dose. | All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 8, week 10, week 12, week 24 |
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| Secondary | Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1000 mg/Day RBV) | C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose. | All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 8, week 10, week 12, week 24 |
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| Secondary | Trough Concentration (Cpre,ss) of Ribavirin at Steady State (Receiving 1200 mg/Day RBV) | C(pre,ss) is defined as pre-dose (trough) concentration of Ribavirin in plasma at steady state immediately before administration of the next dose. | All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 8, week 10, week 12, week 24 |
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| Secondary | Trough Concentration (Cpre,ss) of PegIFN at Steady State | C(pre,ss) is defined as pre-dose (trough) concentration of PegIFN in plasma at steady state immediately before administration of the next dose. | All evaluable patients were included in the pharmacokinetic analysis. A patient was considered to be not evaluable if the patient had a protocol violation relevant to the evaluation of pharmacokinetics or had insufficient data. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | Week 8, week 10, week 12, week 24 |
|
Up to week 72 . Only SAEs related to the study drugs or study design (defined by the investigator) were to be reported from Week 72 up to Week 120.
In the participant flow all randomised patients are counted with their randomised treatment. But for the AE analyses each patient is reported in that treatment which he has actually taken (which could be different from the treatment he was randomised to). In addition, only patients who take at least treatment once are included in the AE analyses.
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-TN | Placebo once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV : PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 2 | 71 | 65 | 71 | ||
| EG001 | 120mg QD/LI-TN | 120 mg BI 201335 (Faldaprevir) once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in (LI) phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 3 | 68 | 65 | 68 | ||
| EG002 | 240mg QD/LI-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 18 | 138 | 135 | 138 | ||
| EG003 | 240mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 12 | 149 | 143 | 149 | ||
| EG004 | 240mg QD/LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 10 | 141 | 135 | 141 | ||
| EG005 | 240mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 5 | 76 | 74 | 76 | ||
| EG006 | 240mg BID/LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] | 13 | 69 | 68 | 69 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anaemia haemolytic autoimmune | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Microvascular angina | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cataract | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Photophobia | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anal fistula | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cyst | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gallbladder polyp | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cryoglobulinaemia | Immune system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| H1N1 influenza | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Perirectal abscess | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
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| Superinfection bacterial | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Benign salivary gland neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MEDDRA 14.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
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| Migraine | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
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| Acute psychosis | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
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| Suicide attempt | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MEDDRA 14.1 | Systematic Assessment |
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| Endometrial hyperplasia | Reproductive system and breast disorders | MEDDRA 14.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
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| Dermatitis atopic | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Erythema multiforme | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Lichen planus | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Parapsoriasis | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Pruritus allergic | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Rash maculo-papular | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Rash pruritic | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
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| Appendicectomy | Surgical and medical procedures | MEDDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Ocular icterus | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
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| Vision blurred | Eye disorders | MEDDRA 14.1 | Systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cheilitis | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Chills | General disorders | MEDDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MEDDRA 14.1 | Systematic Assessment |
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| Influenza like illness | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Irritability | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MEDDRA 14.1 | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MEDDRA 14.1 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MEDDRA 14.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Disturbance in attention | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Mood swings | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MEDDRA 14.1 | 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 BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 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 |
|---|---|
| C552340 | faldaprevir |
| C494814 | BID protein, human |
Not provided
Not provided
Not provided
| Male |
|
240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG002 |
| 240 mg QD-TN |
240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG003 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients
[PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)]
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|
| OG003 | 240 mg QD-TN | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-naive (TN) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG004 | 240 mg QD / LI-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), success-dependently followed by re-randomisation to stop or to an additional 24 weeks of PegIFN/RBV in treatment-experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG005 | 240 mg QD-TE | 240 mg BI 201335 once daily (QD) combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
| OG006 | 240 mg BID / LI-TE | 240 mg BI 201335 twice daily (BID) combined with PegIFN/RBV for 24 weeks, with a 3-day lead-in phase of PegIFN/RBV (i.e. initiation of BI 201335 three days after first administration of PegIFN/RBV), followed by an additional 24 weeks of PegIFN/RBV in treatment experienced (TE) patients [PegIFN/RBV: PegIFN (180 µg/wk) and RBV (1000/1200mg/d)] |
|
|