Trial Outcomes & Findings for Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial (NCT NCT01579474)
NCT ID: NCT01579474
Last Updated: 2015-08-03
Results Overview
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
131 participants
Primary outcome timeframe
Up to 52 weeks
Results posted on
2015-08-03
Participant Flow
Participant milestones
| Measure |
Faldaprevir 120 mg q.d - Cohort I
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Relapser Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
|
Partial Responder Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
44
|
43
|
29
|
3
|
10
|
2
|
|
Overall Study
COMPLETED
|
41
|
30
|
27
|
3
|
9
|
1
|
|
Overall Study
NOT COMPLETED
|
3
|
13
|
2
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Faldaprevir 120 mg q.d - Cohort I
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Relapser Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
|
Partial Responder Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
13
|
2
|
0
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial
Baseline characteristics by cohort
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Relapser Patients - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
Total
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 7.61 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
61.3 years
STANDARD_DEVIATION 6.79 • n=5 Participants
|
47.0 years
STANDARD_DEVIATION 18.08 • n=4 Participants
|
54.9 years
STANDARD_DEVIATION 9.55 • n=21 Participants
|
57.5 years
STANDARD_DEVIATION 14.85 • n=10 Participants
|
56.3 years
STANDARD_DEVIATION 8.97 • n=115 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
72 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
59 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: Safety analyses were based on the safety analysis set (SAF) that included all patients who took the trial medication and were documented to have taken at least 1 dose of the trial medication.
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=44 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Investigator Defined Drug-related Adverse Events
|
43 participants
|
43 participants
|
44 participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level \<25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
|
86.4 percentage of participants
Interval 76.2 to 96.5
|
74.4 percentage of participants
Interval 61.4 to 87.5
|
86.2 percentage of participants
Interval 73.7 to 98.8
|
66.7 percentage of participants
Interval 13.3 to 100.0
|
40.0 percentage of participants
Interval 9.6 to 70.4
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Plasma HCV RNA level \<25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
|
86.4 percentage of participants
Interval 76.2 to 96.5
|
72.1 percentage of participants
Interval 58.7 to 85.5
|
86.2 percentage of participants
Interval 73.7 to 98.8
|
66.7 percentage of participants
Interval 13.3 to 100.0
|
40.0 percentage of participants
Interval 9.6 to 70.4
|
50.0 percentage of participants
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: up to 8 weeksPopulation: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
Plasma HCV RNA level \<25 IU/mL (detected or undetected) at Week 4 and HCV RNA \<25 IU/mL (undetected) at Week 8
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
|
97.7 percentage of participants
|
93.0 percentage of participants
|
96.6 percentage of participants
|
100.0 percentage of participants
|
70.0 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: EOT (up to Week 24 or 48)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes
|
38 participants
|
32 participants
|
25 participants
|
2 participants
|
4 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes, BL normal to EOT normal
|
16 participants
|
18 participants
|
17 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes, BL elevated to EOT normal
|
16 participants
|
10 participants
|
7 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes, no BL or EOT data available
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: EOT (up to Week 24 or 48)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
SVR12=No
|
6 participants
|
11 participants
|
4 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
SVR12=No, BL normal to EOT normal
|
4 participants
|
6 participants
|
3 participants
|
0 participants
|
4 participants
|
0 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
SVR12=No, BL elevated to EOT normal
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
SVR12=No, no BL or EOT data available
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after the EOT (up to Week 36 or 60)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes
|
38 participants
|
32 participants
|
25 participants
|
2 participants
|
4 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes, BL normal to SVR12 normal
|
17 participants
|
18 participants
|
18 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes, BL elevated to SVR12 normal
|
19 participants
|
12 participants
|
7 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes, no BL or SVR12 data available
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after the EOT (up to Week 36 or 60)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No
|
6 participants
|
11 participants
|
4 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No, BL normal to SVR12 normal
|
2 participants
|
4 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No, BL elevated to SVR12 normal
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No, no BL or SVR12 data available
|
1 participants
|
4 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
SECONDARY outcome
Timeframe: EOT (up to Week 24 or 48)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes
|
38 participants
|
32 participants
|
25 participants
|
2 participants
|
4 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes, BL normal to EOT normal
|
21 participants
|
18 participants
|
16 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes, BL elevated to EOT normal
|
11 participants
|
9 participants
|
7 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
SVR12=Yes, no BL or EOT data available
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: EOT (up to Week 24 or 48)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
SVR12=No, BL elevated to EOT normal
|
2 participants
|
3 participants
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
SVR12=No
|
6 participants
|
11 participants
|
4 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
SVR12=No, BL normal to EOT normal
|
4 participants
|
6 participants
|
2 participants
|
1 participants
|
4 participants
|
0 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
SVR12=No, no BL or EOT data available
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after the EOT (up to Week 36 or 60)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes
|
38 participants
|
32 participants
|
25 participants
|
2 participants
|
4 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes, BL normal to SVR12 normal
|
23 participants
|
18 participants
|
18 participants
|
2 participants
|
1 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes, BL elevated to SVR12 normal
|
13 participants
|
12 participants
|
7 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
SVR12=Yes, no BL or SVR12 data available
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 12 weeks after the EOT (up to Week 36 or 60)Population: FAS (All patients who were randomized and received at least 1 dose of the trial medication)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
Outcome measures
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 Participants
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=29 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
Partial Responder Patients - Cohort II
n=3 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
|
Null Responder Patients - Cohort II
n=10 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
|
Breakthrough Patients - Cohort II
n=2 Participants
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
|
|---|---|---|---|---|---|---|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No
|
6 participants
|
11 participants
|
4 participants
|
1 participants
|
6 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No, no BL or SVR12 data available
|
1 participants
|
4 participants
|
1 participants
|
0 participants
|
2 participants
|
1 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No, BL normal to SVR12 normal
|
2 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
SVR12=No, BL elevated to SVR12 normal
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Faldaprevir 120 mg q.d - Cohort I
Serious events: 3 serious events
Other events: 44 other events
Deaths: 0 deaths
Faldaprevir 240 mg q.d - Cohort I
Serious events: 4 serious events
Other events: 43 other events
Deaths: 0 deaths
Faldaprevir 240 mg q.d - Cohort II
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 participants at risk
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 participants at risk
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=44 participants at risk
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
0.00%
0/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
0.00%
0/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
General disorders
Malaise
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Infections and infestations
Renal abscess
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
0.00%
0/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
Other adverse events
| Measure |
Faldaprevir 120 mg q.d - Cohort I
n=44 participants at risk
Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort I
n=43 participants at risk
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
|
Faldaprevir 240 mg q.d - Cohort II
n=44 participants at risk
Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
27.3%
12/44 • Up to 48 weeks + 30 days
|
37.2%
16/43 • Up to 48 weeks + 30 days
|
29.5%
13/44 • Up to 48 weeks + 30 days
|
|
Blood and lymphatic system disorders
Leukopenia
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
4.7%
2/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.5%
9/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
7.0%
3/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Eye disorders
Dry eye
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
11.6%
5/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Eye disorders
Retinal exudates
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Eye disorders
Retinopathy
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
14.0%
6/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
7.0%
3/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
7.0%
3/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Cheilitis
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Constipation
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
14.0%
6/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
7/44 • Up to 48 weeks + 30 days
|
44.2%
19/43 • Up to 48 weeks + 30 days
|
52.3%
23/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Dyspepsia
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Nausea
|
40.9%
18/44 • Up to 48 weeks + 30 days
|
55.8%
24/43 • Up to 48 weeks + 30 days
|
63.6%
28/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Stomatitis
|
13.6%
6/44 • Up to 48 weeks + 30 days
|
14.0%
6/43 • Up to 48 weeks + 30 days
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
|
Gastrointestinal disorders
Vomiting
|
22.7%
10/44 • Up to 48 weeks + 30 days
|
46.5%
20/43 • Up to 48 weeks + 30 days
|
47.7%
21/44 • Up to 48 weeks + 30 days
|
|
General disorders
Fatigue
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
18.2%
8/44 • Up to 48 weeks + 30 days
|
|
General disorders
Injection site erythema
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
7.0%
3/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
General disorders
Injection site reaction
|
29.5%
13/44 • Up to 48 weeks + 30 days
|
37.2%
16/43 • Up to 48 weeks + 30 days
|
22.7%
10/44 • Up to 48 weeks + 30 days
|
|
General disorders
Malaise
|
27.3%
12/44 • Up to 48 weeks + 30 days
|
18.6%
8/43 • Up to 48 weeks + 30 days
|
22.7%
10/44 • Up to 48 weeks + 30 days
|
|
General disorders
Pyrexia
|
79.5%
35/44 • Up to 48 weeks + 30 days
|
76.7%
33/43 • Up to 48 weeks + 30 days
|
79.5%
35/44 • Up to 48 weeks + 30 days
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
13.6%
6/44 • Up to 48 weeks + 30 days
|
14.0%
6/43 • Up to 48 weeks + 30 days
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
|
Hepatobiliary disorders
Jaundice
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
27.9%
12/43 • Up to 48 weeks + 30 days
|
22.7%
10/44 • Up to 48 weeks + 30 days
|
|
Infections and infestations
Cystitis
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Investigations
Haemoglobin decreased
|
11.4%
5/44 • Up to 48 weeks + 30 days
|
14.0%
6/43 • Up to 48 weeks + 30 days
|
18.2%
8/44 • Up to 48 weeks + 30 days
|
|
Investigations
Neutrophil count decreased
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Investigations
Platelet count decreased
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
|
Investigations
Weight decreased
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
0.00%
0/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Investigations
White blood cell count decreased
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
11.6%
5/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Metabolism and nutrition disorders
Decreased appetite
|
20.5%
9/44 • Up to 48 weeks + 30 days
|
37.2%
16/43 • Up to 48 weeks + 30 days
|
34.1%
15/44 • Up to 48 weeks + 30 days
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
4.7%
2/43 • Up to 48 weeks + 30 days
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
7/44 • Up to 48 weeks + 30 days
|
18.6%
8/43 • Up to 48 weeks + 30 days
|
15.9%
7/44 • Up to 48 weeks + 30 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
6/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
|
Nervous system disorders
Dysgeusia
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
14.0%
6/43 • Up to 48 weeks + 30 days
|
18.2%
8/44 • Up to 48 weeks + 30 days
|
|
Nervous system disorders
Headache
|
34.1%
15/44 • Up to 48 weeks + 30 days
|
30.2%
13/43 • Up to 48 weeks + 30 days
|
31.8%
14/44 • Up to 48 weeks + 30 days
|
|
Nervous system disorders
Hypoaesthesia
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
2.3%
1/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Psychiatric disorders
Insomnia
|
22.7%
10/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
7.0%
3/43 • Up to 48 weeks + 30 days
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
0.00%
0/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.1%
15/44 • Up to 48 weeks + 30 days
|
32.6%
14/43 • Up to 48 weeks + 30 days
|
38.6%
17/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
4.7%
2/43 • Up to 48 weeks + 30 days
|
9.1%
4/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
16.3%
7/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
9.3%
4/43 • Up to 48 weeks + 30 days
|
2.3%
1/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.5%
2/44 • Up to 48 weeks + 30 days
|
0.00%
0/43 • Up to 48 weeks + 30 days
|
6.8%
3/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
7.0%
3/43 • Up to 48 weeks + 30 days
|
0.00%
0/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
29.5%
13/44 • Up to 48 weeks + 30 days
|
18.6%
8/43 • Up to 48 weeks + 30 days
|
27.3%
12/44 • Up to 48 weeks + 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
40.9%
18/44 • Up to 48 weeks + 30 days
|
60.5%
26/43 • Up to 48 weeks + 30 days
|
52.3%
23/44 • Up to 48 weeks + 30 days
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER