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Trial record 16 of 16 for:    IU/mL | BI 201335 OR faldaprevir

This Trial Evaluates Safety, Pharmacokinetic Profile and Anti-viral Response of BI 207127 and BI 201335 for Patients With Chronic Hepatitis C

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ClinicalTrials.gov Identifier: NCT01528735
Recruitment Status : Completed
First Posted : February 8, 2012
Results First Posted : April 13, 2016
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: BI 207127 NA
Drug: peginterferon
Drug: Ribavirin
Drug: BI 201335 NA
Enrollment 25
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Period Title: Treatment Period 1: Faldap/Del/RBV
Started 12 13
Completed 11 12
Not Completed 1 1
Reason Not Completed
Adverse Event             1             1
Period Title: Treatment Period 2: Faldap/PegIFN/RBV
Started 11 12 [1]
Completed 10 12
Not Completed 1 0
Reason Not Completed
Withdrawal by Subject             1             0
[1]
One patient was treated with only PegIFN/RBV, as faldaprevir was discontinued due to adverse events
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir Total
Hide Arm/Group Description Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV). Total of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
57.7  (7.38) 55.5  (8.42) 56.5  (7.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
8
  66.7%
8
  61.5%
16
  64.0%
Male
4
  33.3%
5
  38.5%
9
  36.0%
1.Primary Outcome
Title Number of Patients With Drug-related Adverse Events
Hide Description Number of patients with investigator defined drug-related Adverse Events
Time Frame From first dose of study medication until 30 days after last dose of study medication, up to 199 days
Hide Outcome Measure Data
Hide Analysis Population Description
Treated Set which included all patients who were dispensed study medication and were documented to have taken at least one dose of study medication.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: participants
12 13
2.Secondary Outcome
Title Percentage of Participants With Virological Response at Week 4
Hide Description Percentage of participants with plasma HCV RNA (hepatitis C virus (HCV) ribonucleic acid (RNA)) level <25 IU/mL (undetected or detected) at week 4.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of participants
91.7 92.3
3.Secondary Outcome
Title Percentage of Participants With Virological Response at Week 8
Hide Description Percentage of participants with plasma HCV RNA (hepatitis C virus ribonucleic acid ) level <25 IU/mL (undetected or detected) at week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set which included all patients with at least 1 on-treatment value of HCV RNA viral load
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: percentage of participants
91.7 100.0
4.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of Deleobuvir
Hide Description Maximum measured concentration of BI 207127 (Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1 (N=9, 12)
12800
(57.3%)
18800
(55.8%)
Day 11 (N=11, 12)
30100
(71.6%)
50300
(35.4%)
Day 57 (N=11, 13)
18800
(61.0%)
41900
(51.6%)
5.Secondary Outcome
Title Time From Last Dosing to the Maximum Concentration (Tmax) of Deleobuvir
Hide Description Time from last dosing to the maximum concentration of Deleobuvir (BI 207127) in plasma after the morning dose of Nth day (Tmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Median (Full Range)
Unit of Measure: hours
Day 1 (N=9, 12)
3.97
(3.83 to 6.02)
5.03
(1.97 to 7.87)
Day 11 (N=11, 12)
3.92
(1.92 to 5.92)
3.94
(1.90 to 6.00)
Day 57 (N=11, 13)
4.00
(1.83 to 6.05)
3.98
(1.97 to 6.08)
6.Secondary Outcome
Title Area Under the Curve (AUC) of Deleobuvir
Hide Description Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
Day 1 (N=9, 12)
77500
(57.0%)
118000
(59.8%)
Day 11 (N=11, 12)
216000
(104%)
404000
(52.3%)
Day 57 (N=10, 13)
111000
(102%)
326000
(64.8%)
7.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of Faldaprevir
Hide Description Maximum measured concentration of Faldaprevir (BI 201335 ZW) in plasma following the morning dose of Nth day (Cmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 (N=9, 12)
3380
(43.9%)
6440
(46.9%)
Day 11 (N=11, 12)
8530
(76.0%)
20400
(39.7%)
Day 57 (N=11, 13)
4750
(65.1%)
18700
(59.0%)
8.Secondary Outcome
Title Time From Last Dosing to the Maximum Concentration (Tmax) of Faldaprevir
Hide Description Time from last dosing to the maximum concentration of Faldaprevir (BI 201335 ZW) in plasma after the morning dose of Nth day (Tmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Median (Full Range)
Unit of Measure: hours
Day 1 (N=9, 12)
3.97
(3.83 to 6.02)
5.98
(3.97 to 23.8)
Day 11 (N=11, 12)
3.92
(1.92 to 9.83)
4.00
(1.90 to 9.80)
Day 57 (N=11, 13)
3.92
(1.83 to 6.05)
3.97
(1.97 to 7.93)
9.Secondary Outcome
Title Area Under the Curve (AUC) of Faldaprevir
Hide Description Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
Day 1 (N=9, 9)
42900
(53.0%)
107000
(36.4%)
Day 11 (N=11, 10)
119000
(113%)
360000
(50.8%)
Day 57 (N=10, 11)
58700
(115%)
291000
(78.5%)
10.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of BI 208333
Hide Description Maximum measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1 (N=9, 12)
2600
(64.2%)
3630
(76.8%)
Day 11 (N=11, 12)
11100
(92.5%)
20800
(80.5%)
Day 57 (N=11, 13)
4630
(74.0%)
14600
(92.7%)
11.Secondary Outcome
Title Time From Last Dosing to the Maximum Concentration (Tmax) of BI 208333
Hide Description Time from last dosing to the maximum concentration of BI 208333 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Median (Full Range)
Unit of Measure: hours
Day 1 (N=9, 12)
6.00
(3.97 to 8.00)
7.80
(4.05 to 10.0)
Day 11 (N=11, 12)
5.90
(3.83 to 7.98)
3.99
(1.83 to 8.00)
Day 57 (N=11, 13)
5.97
(3.87 to 6.13)
5.98
(3.97 to 10.0)
12.Secondary Outcome
Title Area Under the Curve (AUC) of BI 208333
Hide Description Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
Day 1 (N=9, 12)
19900
(67.5%)
26000
(69.5%)
Day 11 (N=11, 12)
94200
(137%)
210000
(82.9%)
Day 57 (N=10, 13)
38400
(109%)
141000
(112%)
13.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of CD 6168
Hide Description Maximum measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1 (N=9, 12)
1640
(73.7%)
1920
(75.5%)
Day 11 (N=11, 12)
12200
(144%)
23400
(40.4%)
Day 57 (N=11, 13)
7150
(109%)
21000
(62.3%)
14.Secondary Outcome
Title Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168
Hide Description Time from last dosing to the maximum concentration of CD 6168 (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Median (Full Range)
Unit of Measure: hours
Day 1 (N=9, 12)
8.00
(6.00 to 11.9)
9.81
(5.97 to 11.8)
Day 11 (N=11, 12)
3.95
(1.83 to 9.83)
3.94
(1.90 to 6.00)
Day 57 (N=11, 13)
5.83
(3.85 to 6.13)
4.10
(1.97 to 11.8)
15.Secondary Outcome
Title Area Under the Curve (AUC) of CD 6168
Hide Description Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
Day 1 (N=8, 10)
11200
(82.7%)
13200
(75.1%)
Day 11 (N=11, 12)
111000
(177%)
234000
(47.5%)
Day 57 (N=10, 12)
61400
(157%)
191000
(73.3%)
16.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of CD 6168-AG
Hide Description Maximum measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma following the morning dose of Nth day (Cmax,N). AG=acylglucuronide.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Day 1 (N=9, 12)
73.7
(81.3%)
106
(85.2%)
Day 11 (N=11, 12)
691
(132%)
2020
(71.7%)
Day 57 (N=11, 13)
455
(97.6%)
1780
(75.3%)
17.Secondary Outcome
Title Time From Last Dosing to the Maximum Concentration (Tmax) of CD 6168-AG
Hide Description Time from last dosing to the maximum concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the morning dose of Nth day (Tmax,N). AG=acylglucuronide.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Median (Full Range)
Unit of Measure: hours
Day 1 (N=9, 12)
8.00
(7.80 to 11.8)
9.93
(7.95 to 11.8)
Day 11 (N=11, 12)
5.90
(1.85 to 9.83)
4.96
(2.00 to 9.83)
Day 57 (N=11, 13)
5.85
(3.85 to 6.13)
6.08
(4.00 to 11.8)
18.Secondary Outcome
Title Area Under the Curve (AUC) of CD 6168-AG
Hide Description Area under the concentration time curve (AUC) of the analyte in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ. AG=acylglucuronide.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol*h/L
Day 1
NA [1] 
(NA%)
NA [1] 
(NA%)
Day 11 (N=11, 12)
6460
(152%)
20700
(76.6%)
Day 57 (N=10, 12)
4110
(122%)
17700
(87.2%)
[1]
Not calculated because parameters of 2/3rds of the subjects cannot be derived due to limitation of the data or vomiting.
19.Secondary Outcome
Title Maximum Measured Concentration (Cmax) of RBV
Hide Description Maximum measured concentration of ribavirin (RBV) in plasma following the morning dose of Nth day (Cmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 (N=9, 13)
537
(27.1%)
601
(58.1%)
Day 57 (N=9, 11)
2560
(21.8%)
2740
(31.8%)
20.Secondary Outcome
Title Time From Last Dosing to the Maximum Concentration (Tmax) of RBV
Hide Description Time from last dosing to the maximum concentration of ribavirin (RBV) in plasma after the morning dose of Nth day (Tmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Median (Full Range)
Unit of Measure: hours
Day 1 (N=9, 13)
2.00
(1.82 to 4.02)
3.95
(1.87 to 6.05)
Day 57 (N=9, 11)
2.08
(1.83 to 4.13)
2.03
(1.95 to 4.00)
21.Secondary Outcome
Title Area Under the Curve (AUC) of RBV
Hide Description Area under the concentration time curve (AUC) of ribavirin (RBV) in plasma after the morning dose on the Nth day (AUCτ,N) and at steady state (AUCτ,ss), over a uniform dosing interval τ.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*h/mL
Day 1 (N=9, 13)
3410
(19.0%)
3730
(57.6%)
Day 57 (N=8, 10)
25700
(22.7%)
27600
(39.1%)
22.Secondary Outcome
Title Cmax Accumulation Ratio (RA,Cmax,N) of Deleobuvir
Hide Description Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of Deleobuvir versus itself (RA,Cmax,Met,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,Cmax,11 (N=11, 12)
2.33
(50.9%)
2.68
(47.3%)
RA,Cmax,57 (N=11, 13)
1.46
(53.2%)
2.20
(53.6%)
RA,Cmax,Met,ss (N=11, 13)
1.00
(0%)
1.00
(0%)
23.Secondary Outcome
Title AUC Accumulation Ratio of Deleobuvir
Hide Description Accumulation ratio of BI 207127 (Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of Deleobuvir versus itself (RA,AUC,Met,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,AUC,11 (N=11, 12)
2.60
(62.5%)
3.43
(43.3%)
RA,AUC,57 (N=10, 13)
1.21
(71.3%)
2.74
(58.9%)
RA,AUC,tau,Met,ss (N=10, 13)
1.00
(0%)
1.00
(0%)
24.Secondary Outcome
Title Mean Residence Time (MRTpo,ss) of Deleobuvir
Hide Description Mean residence time of BI 207127 (Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set which included all evaluable patients. 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. Analysis includes patients with available data for this parameter.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 10 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hours
6.65
(39.0%)
12.6
(52.2%)
25.Secondary Outcome
Title Apparent Clearance (CL/F,ss) of Deleobuvir
Hide Description Apparent clearance of BI 207127 (Deleobuvir) in plasma following extravascular administration on the 57th day (CL/F,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set which included all evaluable patients. 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. Analysis includes patients with available data for this parameter.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 10 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Litres per hour
8.25
(102%)
2.81
(64.8%)
26.Secondary Outcome
Title Predose Measured Concentration of Deleobuvir
Hide Description Predose measured concentration of BI 207127 (Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cpre,11 (N=9, 12)
10700
(217%)
23500
(61.1%)
Cpre,ss (N=11, 13)
3280
(234%)
16599
(109%)
27.Secondary Outcome
Title Cmax Accumulation Ratio (RA,Cmax,N) of Faldaprevir
Hide Description Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,Cmax,11 (N=11, 12)
2.72
(56.1%)
3.17
(55.4%)
RA,Cmax,57 (N=11, 13)
1.51
(68.0%)
3.00
(81.7%)
28.Secondary Outcome
Title AUC Accumulation Ratio of Faldaprevir
Hide Description Accumulation ratio of Faldaprevir (BI 201335 ZW) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA, AUC,11 (N=11, 9)
2.88
(73.0%)
3.31
(43.3%)
RA,AUC,57 (N=10, 9)
1.28
(96.6%)
2.26
(57.6%)
29.Secondary Outcome
Title Mean Residence Time (MRTpo,ss) of Faldaprevir
Hide Description

Mean residence time of Faldaprevir (BI 201335 ZW) in the body after oral administration at steady state (MRTpo,ss).

This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.

Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Apparent Clearance (CL/F,ss) of Faldaprevir
Hide Description Apparent clearance of Faldaprevir (BI 201335 ZW) in plasma following extravascular administration on the 57th day (CL/F,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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. Analysis includes patients with available data for this parameter.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 10 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/min
22.7
(114%)
6.87
(78.5%)
31.Secondary Outcome
Title Predose Measured Concentration of Faldaprevir
Hide Description Predose measured concentration of Faldaprevir (BI 201335 ZW) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cpre,11 (N=9, 12)
4250
(143%)
13800
(47.5%)
Cpre,ss (N=11, 12)
1540
(176%)
9980
(92.6%)
32.Secondary Outcome
Title Cmax Accumulation Ratio of BI 208333
Hide Description Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of BI 208333 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,Cmax,11 (N=11, 12)
3.82
(81.2%)
5.73
(36.2%)
RA,Cmax,57 (N=11, 13)
1.60
(85.2%)
3.99
(61.2%)
RA,Cmax,Met,ss (N=11, 13)
0.345
(24.1%)
0.349
(64.0%)
33.Secondary Outcome
Title AUC Accumulation Ratio of BI 208333
Hide Description Accumulation ratio of BI 208333 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of BI 208333 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,AUC,11 (N=11, 12)
4.16
(106%)
8.10
(39.6%)
RA,AUC,57 (N=110 13)
1.48
(137%)
4.92
(60.9%)
RA,AUC,tau,Met,ss (N=10, 13)
0.345
(24.1%)
0.431
(57.9%)
34.Secondary Outcome
Title Mean Residence Time (MRTpo,ss) of BI 208333
Hide Description

Mean residence time of BI 208333 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).

This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.

Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
35.Secondary Outcome
Title Predose Measured Concentration of BI 208333
Hide Description Predose measured concentration of BI 208333 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and 23h 50min after drug administration on days 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cpre,11 (N=9, 13)
7450
(186%)
16800
(87.1%)
Cpre,ss (N=11, 13)
1630
(241%)
10700
(125%)
36.Secondary Outcome
Title Cmax Accumulation Ratio of CD 6168
Hide Description Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168 versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,Cmax,11 (N=10, 12)
8.34
(78.5%)
12.2
(71.8%)
RA,Cmax,57 (N=11, 13)
4.90
(75.4%)
10.9
(82.5%)
RA,Cmax,Met,ss (N=11, 13)
0.380
(47.7%)
0.500
(34.6%)
37.Secondary Outcome
Title AUC Accumulation Ratio of CD 6168
Hide Description Accumulation ratio of CD 6168 (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168 versus AUC,ss of Deleobuvir (RA,AUC,Met,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,AUC,11 (N=10, 10)
9.57
(74.9%)
17.0
(75.4%)
RA,AUC,57 (N=9, 11)
5.14
(106%)
14.2
(92.5%)
RA,AUC,tau,Met,ss (N=10, 12)
0.552
(48.0%)
0.600
(24.6%)
38.Secondary Outcome
Title Mean Residence Time (MRTpo,ss) of CD 6168
Hide Description

Mean residence time of CD 6168 (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss).

This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.

Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
39.Secondary Outcome
Title Predose Measured Concentration of CD 6168
Hide Description Predose measured concentration of CD 6168 (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cpre,11 (N=9, 13)
9610
(246%)
17600
(76.7%)
Cpre,ss (N=11, 13)
3190
(279%)
13100
(82.6%)
40.Secondary Outcome
Title Cmax Accumulation Ratio of CD 6168-AG
Hide Description Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the Nth day and after the first dose (RA,Cmax,N), and ratio of the Cmax,ss of CD 6168-AG versus Cmax,ss of Deleobuvir (RA,Cmax,Met,ss). AG=acylglucuronide.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,Cmax,11 (N=11, 8)
10.8
(105%)
NA [1] 
(NA%)
RA,Cmax,57 (N=11, 13)
7.11
(109%)
17.2
(89.8%)
RA,Cmax,Met,ss (N=11, 13)
0.0242
(45.4%)
0.0424
(53.9%)
[1]
Not calculable as per Boehringer Ingelheim internal rules summary statistics are not calculated when less than 2/3rds of patients have available data.
41.Secondary Outcome
Title AUC Accumulation Ratio of CD 6168-AG
Hide Description Accumulation ratio of CD 6168-AG (a metabolite of Deleobuvir) in plasma after the administration of the Nth day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the Nth day and after the first dose (RA,AUC,N), and ratio of the AUC,ss of CD 6168-AG versus AUC,ss of Deleobuvir (RA,AUC,Met,ss). AG=acylglucuronide.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 1, 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
RA,AUC,11 (N=11, 8)
16.7
(122%)
NA [1] 
(NA%)
RA,AUC,57 (N=9, 8)
8.06
(163%)
NA [1] 
(NA%)
RA,AUC,tau,Met,ss (N=10, 12)
0.0369
(36.6%)
0.0557
(46.2%)
[1]
Not calculable as per Boehringer Ingelheim internal rules summary statistics are not calculated when less than 2/3rds of patients have available data.
42.Secondary Outcome
Title Mean Residence Time (MRTpo,ss) of CD 6168-AG
Hide Description

Mean residence time of CD 6168-AG (a metabolite of Deleobuvir) in the body after oral administration at steady state (MRTpo,ss). AG=acylglucuronide.

This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.

Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
43.Secondary Outcome
Title Predose Measured Concentration of CD 6168-AG
Hide Description Predose measured concentration of CD 6168-AG (a metabolite of Deleobuvir) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss). AG=acylglucuronide.
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h, 11h 50min and and 23h 50min after drug administration on days 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nmol/L
Cpre,11 (N=9, 13)
566
(154%)
1630
(73.9%)
Cpre,ss (N=11, 13)
211
(197%)
1350
(82.8%)
44.Secondary Outcome
Title AUC Accumulation Ratio of RBV
Hide Description Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of AUC after the morning dose of the 57th day and after the first dose (RA,AUC,57).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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. Analysis includes patients with available data for this parameter.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 8 10
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
8.03
(17.5%)
6.89
(60.8%)
45.Secondary Outcome
Title Cmax Accumulation Ratio (RA,Cmax,57) of RBV
Hide Description Accumulation ratio of ribavirin (RBV) in plasma after the administration of the 57th day over a uniform dosing interval tau, expressed as a ratio of Cmax after the morning dose of the 57th day and after the first dose (RA,Cmax,57).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 1 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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. Analysis includes patients with available data for this parameter.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 9 11
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Ratio
5.05
(22.5%)
4.89
(67.6%)
46.Secondary Outcome
Title Mean Residence Time (MRTpo,ss) of RBV
Hide Description

Mean residence time of ribavirin (RBV) in the body after oral administration at steady state (MRTpo,ss).

This endpoint was not analysed as the parameter was not calculable for all patients in both treatment groups.

Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on day 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
47.Secondary Outcome
Title Predose Measured Concentration of RBV
Hide Description Predose measured concentration of ribavirin (RBV) in plasma before the morning dose of the Nth day (Cpre,N) and at steady state (Cpre,ss).
Time Frame 10 minutes (min) before drug administration and 2 hours (h), 4h, 6h, 8h, 10h and 11h 50min after drug administration on days 11 and 57
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set which included all evaluable patients. 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.
Arm/Group Title 600mg Deleobuvir and 80mg Faldaprevir 600mg Deleobuvir and 120mg Faldaprevir
Hide Arm/Group Description:
Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
Overall Number of Participants Analyzed 11 13
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Cpre,11 (N=9, 13)
1400
(26.8%)
1290
(31.8%)
Cpre,ss (N=10, 12)
2080
(25.6%)
2110
(38.6%)
Time Frame From first dose of study medication until 30 days after last dose of study medication, up to 199 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Faldap/Del/RBV:80mg Faldap and 600mg Del. Faldap/Del/RBV:120mg Faldap and 600mg Del. Faldap/pegIFN/RBV:80mg Faldap and 600mg Del. Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.
Hide Arm/Group Description Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV) Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV) Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
All-Cause Mortality
Faldap/Del/RBV:80mg Faldap and 600mg Del. Faldap/Del/RBV:120mg Faldap and 600mg Del. Faldap/pegIFN/RBV:80mg Faldap and 600mg Del. Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Faldap/Del/RBV:80mg Faldap and 600mg Del. Faldap/Del/RBV:120mg Faldap and 600mg Del. Faldap/pegIFN/RBV:80mg Faldap and 600mg Del. Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%)   1/11 (9.09%)   0/12 (0.00%) 
Infections and infestations         
Gastroenteritis viral  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Faldap/Del/RBV:80mg Faldap and 600mg Del. Faldap/Del/RBV:120mg Faldap and 600mg Del. Faldap/pegIFN/RBV:80mg Faldap and 600mg Del. Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   12/12 (100.00%)   13/13 (100.00%)   11/11 (100.00%)   11/12 (91.67%) 
Blood and lymphatic system disorders         
Anaemia  1  3/12 (25.00%)  0/13 (0.00%)  0/11 (0.00%)  3/12 (25.00%) 
Iron deficiency anaemia  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Neutropenia  1  0/12 (0.00%)  0/13 (0.00%)  3/11 (27.27%)  4/12 (33.33%) 
Thrombocytopenia  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Eye disorders         
Conjunctival hyperaemia  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Conjunctivitis  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Eyelid oedema  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Ocular hyperaemia  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Retinal degeneration  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Retinal exudates  1  0/12 (0.00%)  1/13 (7.69%)  1/11 (9.09%)  1/12 (8.33%) 
Retinal haemorrhage  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  1/12 (8.33%) 
Retinal tear  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Retinopathy  1  0/12 (0.00%)  0/13 (0.00%)  2/11 (18.18%)  0/12 (0.00%) 
Scintillating scotoma  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Gastrointestinal disorders         
Abdominal discomfort  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Abdominal distension  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Abdominal pain upper  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  1/12 (8.33%) 
Cheilitis  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Constipation  1  2/12 (16.67%)  1/13 (7.69%)  0/11 (0.00%)  1/12 (8.33%) 
Diarrhoea  1  4/12 (33.33%)  4/13 (30.77%)  3/11 (27.27%)  0/12 (0.00%) 
Dyspepsia  1  1/12 (8.33%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Epigastric discomfort  1  2/12 (16.67%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Gastrooesophageal reflux disease  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Nausea  1  8/12 (66.67%)  10/13 (76.92%)  3/11 (27.27%)  1/12 (8.33%) 
Oral discomfort  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Stomatitis  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  2/12 (16.67%) 
Vomiting  1  4/12 (33.33%)  8/13 (61.54%)  2/11 (18.18%)  2/12 (16.67%) 
General disorders         
Asthenia  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Chest pain  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Fatigue  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  1/12 (8.33%) 
Injection site erythema  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Injection site pain  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Injection site reaction  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  3/12 (25.00%) 
Malaise  1  2/12 (16.67%)  0/13 (0.00%)  2/11 (18.18%)  1/12 (8.33%) 
Mass  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Oedema peripheral  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Pain  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  3/12 (25.00%) 
Pyrexia  1  0/12 (0.00%)  1/13 (7.69%)  2/11 (18.18%)  3/12 (25.00%) 
Hepatobiliary disorders         
Hepatic function abnormal  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Hepatic steatosis  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Hyperbilirubinaemia  1  0/12 (0.00%)  4/13 (30.77%)  0/11 (0.00%)  0/12 (0.00%) 
Jaundice  1  0/12 (0.00%)  2/13 (15.38%)  0/11 (0.00%)  0/12 (0.00%) 
Infections and infestations         
Bronchitis  1  2/12 (16.67%)  0/13 (0.00%)  0/11 (0.00%)  2/12 (16.67%) 
Cystitis  1  0/12 (0.00%)  0/13 (0.00%)  2/11 (18.18%)  0/12 (0.00%) 
Gingivitis  1  0/12 (0.00%)  1/13 (7.69%)  1/11 (9.09%)  0/12 (0.00%) 
Hordeolum  1  0/12 (0.00%)  1/13 (7.69%)  1/11 (9.09%)  0/12 (0.00%) 
Nasopharyngitis  1  2/12 (16.67%)  1/13 (7.69%)  1/11 (9.09%)  0/12 (0.00%) 
Rhinitis  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Tonsillitis  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Injury, poisoning and procedural complications         
Contusion  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  1/12 (8.33%) 
Excoriation  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Fall  1  1/12 (8.33%)  0/13 (0.00%)  1/11 (9.09%)  1/12 (8.33%) 
Fracture  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Sunburn  1  2/12 (16.67%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Aspartate aminotransferase increased  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Blood pressure increased  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Haemoglobin decreased  1  0/12 (0.00%)  2/13 (15.38%)  3/11 (27.27%)  1/12 (8.33%) 
Neutrophil count decreased  1  0/12 (0.00%)  0/13 (0.00%)  3/11 (27.27%)  2/12 (16.67%) 
Red blood cell count decreased  1  0/12 (0.00%)  1/13 (7.69%)  2/11 (18.18%)  0/12 (0.00%) 
Weight decreased  1  0/12 (0.00%)  2/13 (15.38%)  0/11 (0.00%)  0/12 (0.00%) 
White blood cell count decreased  1  0/12 (0.00%)  0/13 (0.00%)  3/11 (27.27%)  2/12 (16.67%) 
Metabolism and nutrition disorders         
Decreased appetite  1  3/12 (25.00%)  5/13 (38.46%)  1/11 (9.09%)  1/12 (8.33%) 
Dehydration  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Diabetes mellitus  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/12 (8.33%)  0/13 (0.00%)  2/11 (18.18%)  1/12 (8.33%) 
Back pain  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Musculoskeletal stiffness  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Neck pain  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Nervous system disorders         
Dizziness  1  1/12 (8.33%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Dysgeusia  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Headache  1  0/12 (0.00%)  0/13 (0.00%)  3/11 (27.27%)  2/12 (16.67%) 
Hypoaesthesia  1  2/12 (16.67%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Psychiatric disorders         
Agitation  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Depressive symptom  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Insomnia  1  1/12 (8.33%)  2/13 (15.38%)  0/11 (0.00%)  0/12 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Asthma  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Cough  1  0/12 (0.00%)  2/13 (15.38%)  0/11 (0.00%)  1/12 (8.33%) 
Oropharyngeal pain  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Upper respiratory tract inflammation  1  0/12 (0.00%)  2/13 (15.38%)  0/11 (0.00%)  1/12 (8.33%) 
Skin and subcutaneous tissue disorders         
Alopecia  1  0/12 (0.00%)  0/13 (0.00%)  2/11 (18.18%)  2/12 (16.67%) 
Dermatitis contact  1  1/12 (8.33%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Dry skin  1  1/12 (8.33%)  0/13 (0.00%)  1/11 (9.09%)  3/12 (25.00%) 
Eczema  1  0/12 (0.00%)  0/13 (0.00%)  2/11 (18.18%)  3/12 (25.00%) 
Eczema asteatotic  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Erythema  1  2/12 (16.67%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Ingrowing nail  1  0/12 (0.00%)  0/13 (0.00%)  0/11 (0.00%)  1/12 (8.33%) 
Photodermatosis  1  1/12 (8.33%)  1/13 (7.69%)  1/11 (9.09%)  0/12 (0.00%) 
Photosensitivity reaction  1  1/12 (8.33%)  2/13 (15.38%)  0/11 (0.00%)  0/12 (0.00%) 
Pigmentation disorder  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Pruritus  1  2/12 (16.67%)  3/13 (23.08%)  4/11 (36.36%)  2/12 (16.67%) 
Psoriasis  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Rash  1  0/12 (0.00%)  7/13 (53.85%)  3/11 (27.27%)  3/12 (25.00%) 
Urticaria  1  0/12 (0.00%)  0/13 (0.00%)  1/11 (9.09%)  0/12 (0.00%) 
Social circumstances         
Tanning  1  0/12 (0.00%)  1/13 (7.69%)  0/11 (0.00%)  0/12 (0.00%) 
Vascular disorders         
Hypertension  1  1/12 (8.33%)  0/13 (0.00%)  0/11 (0.00%)  0/12 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MEDDRA 16.1
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
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01528735     History of Changes
Other Study ID Numbers: 1241.25
First Submitted: February 6, 2012
First Posted: February 8, 2012
Results First Submitted: January 21, 2016
Results First Posted: April 13, 2016
Last Update Posted: April 13, 2016