Trial Outcomes & Findings for Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients (NCT NCT00947349)
NCT ID: NCT00947349
Last Updated: 2015-07-07
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
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
4 weeks
Results posted on
2015-07-07
Participant Flow
Participant milestones
| Measure |
Placebo in Treatment Naive (TN) Patients
Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
|
BI 201335 NA Low for Treatment Naive (TN)
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
|
BI 201335 NA High TN
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
|
BI 201335 NA High for Treatment Experienced (TE)
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
|
|---|---|---|---|---|
|
Triple Treatment Combination Period
STARTED
|
4
|
6
|
6
|
6
|
|
Triple Treatment Combination Period
COMPLETED
|
4
|
5
|
6
|
6
|
|
Triple Treatment Combination Period
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Overall Study Standard of Care
STARTED
|
4
|
5
|
6
|
6
|
|
Overall Study Standard of Care
COMPLETED
|
4
|
5
|
4
|
4
|
|
Overall Study Standard of Care
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Placebo in Treatment Naive (TN) Patients
Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
|
BI 201335 NA Low for Treatment Naive (TN)
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
|
BI 201335 NA High TN
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
|
BI 201335 NA High for Treatment Experienced (TE)
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
|
|---|---|---|---|---|
|
Triple Treatment Combination Period
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study Standard of Care
Lack of Efficacy
|
0
|
0
|
1
|
1
|
|
Overall Study Standard of Care
Withdrawal by Subject
|
0
|
0
|
1
|
0
|
|
Overall Study Standard of Care
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Rising Oral Doses of BI 201335 as Softgel Capsule in Naive Hepatitis C Virus (HCV) Patients
Baseline characteristics by cohort
| Measure |
Placebo in TN Patients
n=4 Participants
Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
|
BI 201335 NA Low TN
n=6 Participants
Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
|
BI 201335 NA High TN
n=6 Participants
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
|
BI 201335 NA High TE
n=6 Participants
Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
53.5 years
STANDARD_DEVIATION 6.0 • n=93 Participants
|
48.0 years
STANDARD_DEVIATION 13.5 • n=4 Participants
|
56.0 years
STANDARD_DEVIATION 9.2 • n=27 Participants
|
58.0 years
STANDARD_DEVIATION 8.3 • n=483 Participants
|
53.9 years
STANDARD_DEVIATION 10.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomization randomisation.
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 |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Number of Participants With Investigator Defined Drug-related Adverse Events in Triple Combination Therapy
|
3 participants
|
6 participants
|
6 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in triple combination therapy for treatment naive patients and treatment experienced patients.
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Bilirubin, direct
|
0 participants
|
1 participants
|
3 participants
|
4 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Protein, total
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Uric acid
|
2 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Triglyceride
|
0 participants
|
0 participants
|
1 participants
|
4 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase U. pH
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Haematocrit
|
2 participants
|
2 participants
|
3 participants
|
4 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Haemoglobin
|
3 participants
|
3 participants
|
2 participants
|
4 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Red blood cell ct.
|
1 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease White blood cell ct.
|
2 participants
|
4 participants
|
5 participants
|
4 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Platelets
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Eosinophils
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Sodium
|
1 participants
|
2 participants
|
2 participants
|
1 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Potassium
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Decrease Bicarbonate
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Bicarbonate
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Triple Combination Therapy
Increase Bilirubin, total
|
0 participants
|
2 participants
|
6 participants
|
5 participants
|
PRIMARY outcome
Timeframe: 4 weeksPopulation: The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
An assessment of tolerability for the safety of the triple combination therapy with BI 201335 NA, PegIFN α -2a and RBV.
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Assessment of Tolerability in Triple Combination Therapy
Good
|
3 participants
|
5 participants
|
5 participants
|
6 participants
|
|
Assessment of Tolerability in Triple Combination Therapy
Satisfactory
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Assessment of Tolerability in Triple Combination Therapy
Not Satisfactory
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Assessment of Tolerability in Triple Combination Therapy
Bad
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients satisfying W2VR (plasma HCV RNA (Hepatitis C Virus Ribonucleic acid) level below the limit of quantification (BLQ))
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Week 2 Virological Response (W2VR)
|
0 participants
|
5 participants
|
6 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients satisfying W4VR (plasma HCV RNA level below the limit of quantification (BLQ))
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Week 4 Virological Response (W4VR)
|
0 participants
|
6 participants
|
6 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients satisfying RVR (plasma HCV RNA level below the limit of detection (BLD) at Week 4)
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Rapid Virological Response (RVR)
|
0 participants
|
5 participants
|
6 participants
|
4 participants
|
SECONDARY outcome
Timeframe: baseline and week 4Population: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Change form baseline in HCV viral load (log10) after 4 weeks
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Change From Baseline in HCV Viral Load
|
-3.30 IU/mL
Standard Error 0.74
|
-5.88 IU/mL
Standard Error 0.17
|
-5.95 IU/mL
Standard Error 0.21
|
-5.53 IU/mL
Standard Error 0.29
|
SECONDARY outcome
Timeframe: 4 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients with HCV viral load reduction \>= 2 log10 at Week 4
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Day 28 Virologic Response
|
3 participants
|
6 participants
|
6 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 WeeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients with reduction \>= 2 log10 in plasma HCV RNA level at Week 12
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Early Virological Response (EVR)
|
4 participants
|
5 participants
|
6 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients with plasma HCV RNA level BLD at Week 12
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Complete Early Virological Response (cEVR)
|
3 participants
|
5 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients with plasma HCV RNA level BLD at week 48
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
End of Treatment Response (ETR)
|
3 participants
|
5 participants
|
4 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 72 weeksPopulation: The full analysis set (FAS) consisted of all randomised patients who were given investigational products and were documented to have taken at least one dose of study medication.
Number of patients with plasma HCV RNA level BLD 24 weeks after treatment completion
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Sustained Virologic Response (SVR)
|
2 participants
|
4 participants
|
5 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 44 weeksPopulation: The treated set (TS) consisted of all patients who were given study medication and were documented to have taken at least one dose of investigational products regardless of randomisation.
Drug-related AEs in SOC treatment period were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Number of Participants With Investigator Defined Drug-related Adverse Events in Standard of Care (SOC) With PegIFN α-2a and RBV
|
3 participant(s)
|
5 participant(s)
|
4 participant(s)
|
5 participant(s)
|
SECONDARY outcome
Timeframe: 44 weeksPopulation: TS
Frequency of patients with possible clinically significant abnormalities or clinically significant laboratory test value changes over time in SOC period for treatment naive patients and treatment experienced patients.
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease haematocrit
|
1 participant(s)
|
3 participant(s)
|
5 participant(s)
|
4 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease haemoglobin
|
4 participant(s)
|
2 participant(s)
|
2 participant(s)
|
5 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease red blood cell ct.
|
0 participant(s)
|
3 participant(s)
|
4 participant(s)
|
3 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease white blood cell ct.
|
3 participant(s)
|
5 participant(s)
|
5 participant(s)
|
3 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease platelets
|
0 participant(s)
|
1 participant(s)
|
0 participant(s)
|
0 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase eosinophils
|
0 participant(s)
|
0 participant(s)
|
1 participant(s)
|
1 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease sodium
|
1 participant(s)
|
0 participant(s)
|
1 participant(s)
|
0 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Decrease potassium
|
0 participant(s)
|
0 participant(s)
|
1 participant(s)
|
0 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase bicarbonate
|
0 participant(s)
|
1 participant(s)
|
0 participant(s)
|
0 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase uric acid
|
1 participant(s)
|
0 participant(s)
|
0 participant(s)
|
0 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase triglyceride
|
1 participant(s)
|
0 participant(s)
|
0 participant(s)
|
2 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase U. pH
|
0 participant(s)
|
2 participant(s)
|
0 participant(s)
|
0 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase AST/GOT, SGOT
|
0 participant(s)
|
1 participant(s)
|
0 participant(s)
|
1 participant(s)
|
|
Number of Patients With Possible Clinically Significant Laboratory Abnormalities in Standard of Care (SOC) With PegIFN α-2a and RBV
Increase ALT/GPT, SGPT
|
0 participant(s)
|
1 participant(s)
|
0 participant(s)
|
1 participant(s)
|
SECONDARY outcome
Timeframe: 44 weeksPopulation: TS
An assessment of tolerability for the safety of the SOC with PegIFN alfa-2a and RBV.
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
Good
|
2 participant(s)
|
4 participant(s)
|
1 participant(s)
|
3 participant(s)
|
|
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
Satisfactory
|
2 participant(s)
|
0 participant(s)
|
2 participant(s)
|
1 participant(s)
|
|
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
Not satisfactory
|
0 participant(s)
|
1 participant(s)
|
1 participant(s)
|
2 participant(s)
|
|
Assessment of Tolerability in Standard of Care (SOC) With PegIFN α -2a and RBV
Bad
|
0 participant(s)
|
0 participant(s)
|
2 participant(s)
|
0 participant(s)
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Area under the curve (AUC) concentration after the first dose of BI 201335 ZW
Outcome measures
| Measure |
Triple TN Placebo
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
AUCτ,1 for BI 201335 ZW
|
68900 ng*h/mL
Geometric Coefficient of Variation 25.3
|
171000 ng*h/mL
Geometric Coefficient of Variation 21.2
|
233000 ng*h/mL
Geometric Coefficient of Variation 38.5
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Maximum concentration of BI 201335 ZW after multiple oral admin. of BI 201335 NA with RBV and PegIFN alfa-2a
Outcome measures
| Measure |
Triple TN Placebo
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cmax of BI 201335 ZW
|
5500 ng/mL
Geometric Coefficient of Variation 24.4
|
12600 ng/mL
Geometric Coefficient of Variation 29.0
|
15000 ng/mL
Geometric Coefficient of Variation 40.0
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
AUC at steady state after 4 weeks combination of the last dose
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
AUCτ,ss of BI 201335 ZW
|
70800 ng*h/mL
Geometric Coefficient of Variation 86.5
|
361000 ng*h/mL
Geometric Coefficient of Variation 68.0
|
499000 ng*h/mL
Geometric Coefficient of Variation 41.3
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Maximum concentration of BI 201335 ZW at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cmax,ss of BI 201335 ZW
|
5880 ng/mL
Geometric Coefficient of Variation 61.5
|
24500 ng/mL
Geometric Coefficient of Variation 52.2
|
29100 ng/mL
Geometric Coefficient of Variation 35.3
|
—
|
SECONDARY outcome
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Area under the plasma concentration curve of RBV after the first dose of placebo or BI 201335 NA with with RBV and PegIFN alfa-2a
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
AUCτ,1 for Ribavirin (RBV)
|
5160 ng*h/mL
Geometric Coefficient of Variation 22.1
|
4660 ng*h/mL
Geometric Coefficient of Variation 35.8
|
4620 ng*h/mL
Geometric Coefficient of Variation 22.9
|
3500 ng*h/mL
Geometric Coefficient of Variation 41.2
|
SECONDARY outcome
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the first dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Maximum Plasma concentration of RBV after multiple oral admin. of placebo with RBV and PegIFN alfa-2a
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cmax of RBV
|
1130 ng/mL
Geometric Coefficient of Variation 24.9
|
761 ng/mL
Geometric Coefficient of Variation 29.7
|
724 ng/mL
Geometric Coefficient of Variation 33.7
|
509 ng/mL
Geometric Coefficient of Variation 51.0
|
SECONDARY outcome
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Area under the plasma concentration curve of RBV after the multiple oral administration of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
AUCτ,ss of RBV
|
27500 ng*h/mL
Geometric Coefficient of Variation 29.5
|
25200 ng*h/mL
Geometric Coefficient of Variation 42.4
|
22400 ng*h/mL
Geometric Coefficient of Variation 38.5
|
20000 ng*h/mL
Geometric Coefficient of Variation 18.7
|
SECONDARY outcome
Timeframe: -0:10, 1,2,3,4,5,6,8,10,11:50, 23:50 hours on the last dosePopulation: The pharmacokinetic analysis set (PKS) consisted of all randomised patients who took at least one dose of investigational products and with at least one on treatment blood sample available.
Maximum Plasma concentration of RBV after multiple oral admin. of BI 201335 NA (or placebo) with RBV and PegIFN alfa-2a at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cmax,ss of RBV
|
3060 ng/mL
Geometric Coefficient of Variation 35.4
|
2710 ng/mL
Geometric Coefficient of Variation 47.3
|
2280 ng/mL
Geometric Coefficient of Variation 43.2
|
2130 ng/mL
Geometric Coefficient of Variation 18.0
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dosePopulation: PKS
Time to maximum plasma concentration (tmax) of BI 201335 ZW after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Outcome measures
| Measure |
Triple TN Placebo
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Tmax for BI 201335 ZW
|
4.98 hour(s)
Interval 3.92 to 9.88
|
5.50 hour(s)
Interval 4.03 to 7.93
|
7.97 hour(s)
Interval 2.88 to 9.92
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the first dosePopulation: PKS
Time to maximum plasma concentration (tmax) of RBV after the first dose of BI 201335 NA with RBV and PegIFN alfa-2a
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Tmax for RBV
|
1.94 hour(s)
Interval 0.917 to 3.0
|
3.98 hour(s)
Interval 2.0 to 4.88
|
3.92 hour(s)
Interval 2.05 to 5.97
|
4.98 hour(s)
Interval 1.97 to 6.02
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
Time from last dosing to the maximum plasma concentration (tmax) of BI 201335 ZW after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Tmax, ss for BI 201335 ZW
|
3.83 hour(s)
Interval 1.85 to 5.07
|
2.99 hour(s)
Interval 2.9 to 3.05
|
3.49 hour(s)
Interval 2.92 to 4.03
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
Time to the maximum plasma concentration (tmax) of RBV after the last dose of BI 201335 NA with RBV and PegIFN alfa-2a at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Tmax, ss for RBV
|
2.42 hour(s)
Interval 0.9 to 3.93
|
2.92 hour(s)
Interval 1.85 to 4.08
|
2.90 hour(s)
Interval 1.93 to 5.88
|
3.92 hour(s)
Interval 2.0 to 5.03
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
terminal half-life of the analyte in plasma at steady state (t1/2,ss)
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
t1/2,ss for BI 201335 ZW
|
29.3 hour(s)
Geometric Coefficient of Variation 7.70
|
21.2 hour(s)
Geometric Coefficient of Variation 9.00
|
23.0 hour(s)
Geometric Coefficient of Variation 19.8
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
Minimum concentration of the analyte (BI 201335 ZW) in plasma over the dosing interval at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cmin,ss for BI 201335 ZW
|
1550 ng/mL
Geometric Coefficient of Variation 138
|
10200 ng/mL
Geometric Coefficient of Variation 85.0
|
16000 ng/mL
Geometric Coefficient of Variation 54.1
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
Minimum concentration of the analyte (RBV) in plasma over the dosing interval at steady state
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cmin,ss for RBV
|
1980 ng/mL
Geometric Coefficient of Variation 24.6
|
1730 ng/mL
Geometric Coefficient of Variation 44.0
|
1590 ng/mL
Geometric Coefficient of Variation 36.4
|
1400 ng/mL
Geometric Coefficient of Variation 18.5
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
average plasma concentration (Cavg) of BI 201335 ZW
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cavg for BI 201335 ZW
|
2950 ng/mL
Geometric Coefficient of Variation 86.5
|
15000 ng/mL
Geometric Coefficient of Variation 68.0
|
20800 ng/mL
Geometric Coefficient of Variation 41.3
|
—
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
average plasma concentration (Cavg) of RBV
Outcome measures
| Measure |
Triple TN Placebo
n=4 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
n=6 Participants
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
Cavg for RBV
|
2290 ng/mL
Geometric Coefficient of Variation 29.5
|
2100 ng/mL
Geometric Coefficient of Variation 42.4
|
1860 ng/mL
Geometric Coefficient of Variation 38.5
|
1670 ng/mL
Geometric Coefficient of Variation 18.7
|
SECONDARY outcome
Timeframe: 10 minutes before drug administration and 1 hour (h),2h,3h,4h,5h,6h,8h,10h,11:50h, 23:50h on the last dosePopulation: PKS
apparent clearance of the analyte (BI 201335 ZW) in plasma at steady state (CL/F,ss) following multiple oral administration
Outcome measures
| Measure |
Triple TN Placebo
n=5 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
|
Triple TN 120 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
|
Triple TN 240 mg
n=6 Participants
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
Triple TE 240 mg
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
|
|---|---|---|---|---|
|
CL/F,ss for BI 201335 ZW
|
28.2 mL/min
Geometric Coefficient of Variation 86.5
|
11.1 mL/min
Geometric Coefficient of Variation 68.0
|
8.01 mL/min
Geometric Coefficient of Variation 41.3
|
—
|
Adverse Events
Triple TN Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Triple TN 120 mg
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Triple TN 240 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Triple TE 240 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
SOC TN Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
SOC TN 120 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SOC TN 240 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
SOC TE 240 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Triple TN Placebo
n=4 participants at risk
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
|
Triple TN 120 mg
n=6 participants at risk
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
|
Triple TN 240 mg
n=6 participants at risk
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
Triple TE 240 mg
n=6 participants at risk
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
SOC TN Placebo
n=4 participants at risk
Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
|
SOC TN 120 mg
n=5 participants at risk
Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
|
SOC TN 240 mg
n=6 participants at risk
Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
SOC TE 240 mg
n=6 participants at risk
Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
Other adverse events
| Measure |
Triple TN Placebo
n=4 participants at risk
Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
|
Triple TN 120 mg
n=6 participants at risk
Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
|
Triple TN 240 mg
n=6 participants at risk
Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
Triple TE 240 mg
n=6 participants at risk
Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
SOC TN Placebo
n=4 participants at risk
Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
|
SOC TN 120 mg
n=5 participants at risk
Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
|
SOC TN 240 mg
n=6 participants at risk
Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
SOC TE 240 mg
n=6 participants at risk
Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
|
|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Endocrine disorders
Basedow's disease
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Eye disorders
Ocular icterus
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Eye disorders
Pingueculitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Eye disorders
Retinopathy
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Gastritis atrophic
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Lip erosion
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
25.0%
1/4 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Periproctitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
50.0%
3/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Fatigue
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Feeling hot
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Influenza like illness
|
25.0%
1/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Malaise
|
25.0%
1/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Oedema
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Pain
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
General disorders
Pyrexia
|
0.00%
0/4 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
80.0%
4/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Investigations
Haemoglobin decreased
|
25.0%
1/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
60.0%
3/5 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Investigations
Liver function test abnormal
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Investigations
Neutrophil count decreased
|
25.0%
1/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
66.7%
4/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Investigations
Weight decreased
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
40.0%
2/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Psychiatric disorders
Insomnia
|
25.0%
1/4 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
50.0%
2/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
50.0%
2/4 • up to 72 weeks
|
20.0%
1/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
1/4 • up to 72 weeks
|
50.0%
3/6 • up to 72 weeks
|
33.3%
2/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
25.0%
1/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
|
Vascular disorders
Lymphocele
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
0.00%
0/4 • up to 72 weeks
|
0.00%
0/5 • up to 72 weeks
|
16.7%
1/6 • up to 72 weeks
|
0.00%
0/6 • up to 72 weeks
|
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