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Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

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ClinicalTrials.gov Identifier: NCT01399619
Recruitment Status : Completed
First Posted : July 22, 2011
Results First Posted : September 4, 2015
Last Update Posted : August 29, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: PegIFN/RBV
Drug: BI201335
Drug: BI201335 24W
Drug: Bi 201335
Enrollment 310
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Faldaprevir 120mg -24W Faldaprevir 240mg -12W Faldaprevir 240mg-24W Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)
Hide Arm/Group Description Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
Period Title: Overall Study
Started 123 84 86 17
Completed 98 84 74 0
Not Completed 25 0 12 17
Reason Not Completed
Adverse Event             10             0             4             10
Lack of Efficacy             9             0             5             0
Withdrawal by Subject             6             0             3             4
Protocol Violation             0             0             0             1
Not treated             0             0             0             2
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg -T Total
Hide Arm/Group Description Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12. Total of all reporting groups
Overall Number of Baseline Participants 123 185 308
Hide Baseline Analysis Population Description
FAS (All patients who were randomized and received at least one dose of assigned therapy)
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 123 participants 185 participants 308 participants
47.6  (7.63) 46.5  (8.36) 46.9  (8.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 123 participants 185 participants 308 participants
Female
20
  16.3%
40
  21.6%
60
  19.5%
Male
103
  83.7%
145
  78.4%
248
  80.5%
1.Primary Outcome
Title Sustained Virological Response (SVR12)
Hide Description Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment.
Time Frame 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.7
(62.7 to 78.8)
78.6
(69.8 to 87.3)
76.7
(67.8 to 85.7)
72.4
(66.0 to 78.9)
71.8
(66.7 to 76.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Faldaprevir - Total
Comments the SVR12 rate in total Faldaprevir group compared with the historical rate of 40%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments p-value corresponds to a two sided test against the historical rate of 40%.
Method normal approximation
Comments [Not Specified]
2.Secondary Outcome
Title Virological Response 24 Weeks Post Treatment (SVR24)
Hide Description Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment.
Time Frame 72 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
69.9
(61.8 to 78.0)
78.6
(69.8 to 87.3)
74.4
(65.2 to 83.6)
71.4
(64.8 to 77.9)
70.8
(65.7 to 75.9)
3.Secondary Outcome
Title Early Treatment Success (ETS)
Hide Description Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8
Time Frame Week 4, week 8 and week 60
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg -12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
number of subjects with ETS =yes 95 70 73 150 245
number of subjects with SVR12 among ETS=yes group 83 62 63 127 210
4.Secondary Outcome
Title The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes
Hide Description The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=yes 87 66 66 134 221
SVR12=yes, BL normal to EOT normal 29 16 26 43 72
SVR12=yes, BL elevated to EOT normal 45 34 32 66 111
SVR12=yes, No BL or EoT data 0 0 0 1 1
5.Secondary Outcome
Title The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no
Hide Description The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg -12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=no 36 18 20 51 87
SVR12=no, BL normal to EoT normal 18 5 5 18 36
SVR12=no, BL elevated to EoT normal 12 8 9 21 33
SVR12=no, no BL or EoT data available 2 0 0 0 2
6.Secondary Outcome
Title The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes
Hide Description The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Time Frame 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg -24W Faldaprevir 240mg -12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=yes 87 66 66 134 221
SVR12=yes, BL normal to SVR12 normal 28 17 26 45 73
SVR12=yes, BL elevated to SVR12 normal 52 46 35 81 133
SVR12=yes, no ALT data available at SVR12 visit 4 0 1 1 5
7.Secondary Outcome
Title The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no
Hide Description The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Time Frame 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=no 36 18 20 51 87
SVR12=no, BL normal to SVR12 normal 8 1 3 6 14
SVR12=no, BL elevated to SVR12 normal 1 6 3 9 10
SVR12=no, no ALT data available at SVR12 visit 16 4 6 20 36
8.Secondary Outcome
Title The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes
Hide Description The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=yes 87 66 66 134 221
SVR12=yes, BL normal to EoT normal 41 25 28 54 95
SVR12=yes, BL elevated to EoT normal 32 25 27 52 84
SVR12=yes, no BL or EoT data available 0 0 0 1 1
9.Secondary Outcome
Title The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no
Hide Description The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline.
Time Frame 48 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=no 36 18 20 51 87
SVR12=no, BL normal to EoT normal 14 6 7 19 33
SVR12=no, BL elevated to EoT normal 12 6 8 19 31
SVR12=no, no BL or EoT data available 2 0 0 0 2
10.Secondary Outcome
Title The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes
Hide Description The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline.
Time Frame 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=yes 87 66 66 134 221
SVR12=yes, BL normal to SVR12 normal 41 27 28 57 98
SVR12=yes, BL elevated to SVR12 normal 36 36 33 69 105
SVR12=yes, no AST data available at SVR12 visit 4 0 1 1 5
11.Secondary Outcome
Title The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no
Hide Description The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline.
Time Frame 60 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T Faldaprevir - Total
Hide Arm/Group Description:
Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
Total subjects who were treated with Faldaprevir.
Overall Number of Participants Analyzed 123 84 86 185 308
Measure Type: Number
Unit of Measure: participants
SVR12=no 36 18 20 51 87
SVR12=no, BL normal to SVR12 normal 6 4 6 13 19
SVR12=no, BL elevated to SVR12 normal 2 3 0 3 5
SVR12=no, no AST data available at SVR12 visit 16 4 6 20 36
Time Frame from the start date of trial medication up to 52 weeks ( AEs occurred from the start date of trial medication up to four weeks after all treatment discontinuation).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T
Hide Arm/Group Description Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48. Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
All-Cause Mortality
Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/123 (13.82%)   5/84 (5.95%)   5/86 (5.81%)   15/185 (8.11%) 
Blood and lymphatic system disorders         
Anaemia  1  0/123 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  2/185 (1.08%) 
Thrombocytopenia  1  0/123 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  1/185 (0.54%) 
Cardiac disorders         
Acute coronary syndrome  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Acute myocardial infarction  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Endocrine disorders         
Hyperthyroidism  1  0/123 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  1/185 (0.54%) 
Gastrointestinal disorders         
Abdominal pain  1  1/123 (0.81%)  1/84 (1.19%)  1/86 (1.16%)  2/185 (1.08%) 
Diarrhoea  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Enterovesical fistula  1  0/123 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  1/185 (0.54%) 
Nausea  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Vomiting  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
General disorders         
Asthenia  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Pyrexia  1  3/123 (2.44%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Hepatobiliary disorders         
Cholecystitis  1  0/123 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  1/185 (0.54%) 
Immune system disorders         
Sarcoidosis  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Infections and infestations         
Appendicitis  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Diverticulitis  1  0/123 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  1/185 (0.54%) 
Escherichia urinary tract infection  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Gastroenteritis  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Gastroenteritis viral  1  0/123 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  1/185 (0.54%) 
Infected cyst  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Leishmaniasis  1  0/123 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  1/185 (0.54%) 
Neurosyphilis  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Pneumonia  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Pneumonia bacterial  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Pulmonary tuberculosis  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Sepsis  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Urosepsis  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Injury, poisoning and procedural complications         
Accidental overdose  1  0/123 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  1/185 (0.54%) 
Metabolism and nutrition disorders         
Decreased appetite  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Dehydration  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Hypokalaemia  1  0/123 (0.00%)  0/84 (0.00%)  1/86 (1.16%)  1/185 (0.54%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Lymphoma  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Nervous system disorders         
Epilepsy  1  0/123 (0.00%)  1/84 (1.19%)  0/86 (0.00%)  1/185 (0.54%) 
Renal and urinary disorders         
Nephrolithiasis  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Reproductive system and breast disorders         
Benign prostatic hyperplasia  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Skin and subcutaneous tissue disorders         
Drug reaction with eosinophilia and systemic symptoms  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Rash  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Rash erythematous  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Rash maculo-papular  1  2/123 (1.63%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Toxic skin eruption  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Social circumstances         
Substance use  1  0/123 (0.00%)  0/84 (0.00%)  0/86 (0.00%)  1/185 (0.54%) 
Vascular disorders         
Haematoma  1  1/123 (0.81%)  0/84 (0.00%)  0/86 (0.00%)  0/185 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Faldaprevir 120mg - 24W Faldaprevir 240mg - 12W Faldaprevir 240mg - 24W Faldaprevir 240mg -T
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   116/123 (94.31%)   80/84 (95.24%)   84/86 (97.67%)   178/185 (96.22%) 
Blood and lymphatic system disorders         
Anaemia  1  27/123 (21.95%)  13/84 (15.48%)  15/86 (17.44%)  30/185 (16.22%) 
Neutropenia  1  27/123 (21.95%)  6/84 (7.14%)  15/86 (17.44%)  22/185 (11.89%) 
Eye disorders         
Dry eye  1  3/123 (2.44%)  5/84 (5.95%)  0/86 (0.00%)  6/185 (3.24%) 
Gastrointestinal disorders         
Abdominal pain  1  7/123 (5.69%)  11/84 (13.10%)  4/86 (4.65%)  17/185 (9.19%) 
Abdominal pain upper  1  7/123 (5.69%)  7/84 (8.33%)  3/86 (3.49%)  10/185 (5.41%) 
Cheilitis  1  8/123 (6.50%)  4/84 (4.76%)  3/86 (3.49%)  7/185 (3.78%) 
Diarrhoea  1  31/123 (25.20%)  24/84 (28.57%)  23/86 (26.74%)  51/185 (27.57%) 
Dry mouth  1  6/123 (4.88%)  5/84 (5.95%)  2/86 (2.33%)  7/185 (3.78%) 
Dyspepsia  1  6/123 (4.88%)  4/84 (4.76%)  7/86 (8.14%)  11/185 (5.95%) 
Nausea  1  34/123 (27.64%)  38/84 (45.24%)  36/86 (41.86%)  81/185 (43.78%) 
Vomiting  1  12/123 (9.76%)  14/84 (16.67%)  23/86 (26.74%)  43/185 (23.24%) 
General disorders         
Asthenia  1  31/123 (25.20%)  21/84 (25.00%)  17/86 (19.77%)  39/185 (21.08%) 
Chills  1  5/123 (4.07%)  2/84 (2.38%)  7/86 (8.14%)  11/185 (5.95%) 
Fatigue  1  39/123 (31.71%)  29/84 (34.52%)  30/86 (34.88%)  65/185 (35.14%) 
Influenza like illness  1  14/123 (11.38%)  17/84 (20.24%)  12/86 (13.95%)  31/185 (16.76%) 
Injection site reaction  1  3/123 (2.44%)  2/84 (2.38%)  6/86 (6.98%)  8/185 (4.32%) 
Irritability  1  19/123 (15.45%)  8/84 (9.52%)  5/86 (5.81%)  13/185 (7.03%) 
Pyrexia  1  29/123 (23.58%)  11/84 (13.10%)  10/86 (11.63%)  24/185 (12.97%) 
Hepatobiliary disorders         
Jaundice  1  7/123 (5.69%)  8/84 (9.52%)  10/86 (11.63%)  19/185 (10.27%) 
Infections and infestations         
Oral herpes  1  8/123 (6.50%)  0/84 (0.00%)  2/86 (2.33%)  2/185 (1.08%) 
Investigations         
Weight decreased  1  16/123 (13.01%)  10/84 (11.90%)  13/86 (15.12%)  25/185 (13.51%) 
Metabolism and nutrition disorders         
Decreased appetite  1  29/123 (23.58%)  14/84 (16.67%)  18/86 (20.93%)  36/185 (19.46%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  11/123 (8.94%)  6/84 (7.14%)  6/86 (6.98%)  13/185 (7.03%) 
Muscle spasms  1  3/123 (2.44%)  3/84 (3.57%)  6/86 (6.98%)  9/185 (4.86%) 
Myalgia  1  17/123 (13.82%)  9/84 (10.71%)  15/86 (17.44%)  27/185 (14.59%) 
Nervous system disorders         
Dizziness  1  9/123 (7.32%)  10/84 (11.90%)  6/86 (6.98%)  20/185 (10.81%) 
Headache  1  29/123 (23.58%)  21/84 (25.00%)  22/86 (25.58%)  47/185 (25.41%) 
Lethargy  1  1/123 (0.81%)  3/84 (3.57%)  5/86 (5.81%)  8/185 (4.32%) 
Psychiatric disorders         
Anxiety  1  9/123 (7.32%)  5/84 (5.95%)  2/86 (2.33%)  8/185 (4.32%) 
Depressed mood  1  6/123 (4.88%)  4/84 (4.76%)  7/86 (8.14%)  12/185 (6.49%) 
Depression  1  11/123 (8.94%)  9/84 (10.71%)  13/86 (15.12%)  24/185 (12.97%) 
Insomnia  1  29/123 (23.58%)  11/84 (13.10%)  14/86 (16.28%)  28/185 (15.14%) 
Sleep disorder  1  4/123 (3.25%)  3/84 (3.57%)  5/86 (5.81%)  8/185 (4.32%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  13/123 (10.57%)  8/84 (9.52%)  10/86 (11.63%)  18/185 (9.73%) 
Dyspnoea  1  12/123 (9.76%)  8/84 (9.52%)  3/86 (3.49%)  12/185 (6.49%) 
Oropharyngeal pain  1  3/123 (2.44%)  6/84 (7.14%)  2/86 (2.33%)  9/185 (4.86%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  7/123 (5.69%)  4/84 (4.76%)  6/86 (6.98%)  10/185 (5.41%) 
Dry skin  1  17/123 (13.82%)  9/84 (10.71%)  18/86 (20.93%)  27/185 (14.59%) 
Erythema  1  8/123 (6.50%)  5/84 (5.95%)  5/86 (5.81%)  10/185 (5.41%) 
Night sweats  1  7/123 (5.69%)  6/84 (7.14%)  3/86 (3.49%)  9/185 (4.86%) 
Pruritus  1  19/123 (15.45%)  16/84 (19.05%)  17/86 (19.77%)  34/185 (18.38%) 
Rash  1  22/123 (17.89%)  16/84 (19.05%)  13/86 (15.12%)  31/185 (16.76%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 16.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01399619     History of Changes
Other Study ID Numbers: 1220.19
2010-021734-59 ( EudraCT Number: EudraCT )
First Submitted: July 20, 2011
First Posted: July 22, 2011
Results First Submitted: July 3, 2015
Results First Posted: September 4, 2015
Last Update Posted: August 29, 2016