Trial Outcomes & Findings for Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C (NCT NCT01467492)
NCT ID: NCT01467492
Last Updated: 2015-08-03
Results Overview
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
121 participants
Primary outcome timeframe
12 weeks after last actual dose of study drug (up to Week 60)
Results posted on
2015-08-03
Participant Flow
Study included Prior Relapser (prior HCV treatment with pegylated interferon alfa/ribavirin \[Peg-IFN/RBV\] and experienced viral relapse) and Prior Null/Partial Responder (prior HCV treatment with Peg-IFN/RBV and had null/partial response) participants.
Efficacy analyses were reported as per Race (Black/Non-Black) (reporting arms) and also separately as per prior response (in categories) (Prior Relapser, Prior Null Responder, Prior Partial Responder as well as for Total Participants), unless otherwise specified.
Participant milestones
| Measure |
Group A - Black
Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing \<75 kilograms \[kg\]) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
38
|
|
Overall Study
COMPLETED
|
61
|
25
|
|
Overall Study
NOT COMPLETED
|
22
|
13
|
Reasons for withdrawal
| Measure |
Group A - Black
Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing \<75 kilograms \[kg\]) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
4
|
|
Overall Study
Study Terminated by Sponsor
|
6
|
4
|
|
Overall Study
Adverse Event
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
2
|
|
Overall Study
Undefined
|
2
|
0
|
|
Overall Study
Enrolled But Not Treated
|
1
|
0
|
Baseline Characteristics
Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
Baseline characteristics by cohort
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.7 years
STANDARD_DEVIATION 5.59 • n=93 Participants
|
55.8 years
STANDARD_DEVIATION 5.95 • n=4 Participants
|
57.1 years
STANDARD_DEVIATION 5.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after last actual dose of study drug (up to Week 60)Population: FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Prior Null Response (n = 41, 10)
|
26.8 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Prior Partial Response (n= 20, 6)
|
40.0 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Prior Relapse ( n= 21, 22)
|
66.7 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
Total (n= 82, 38)
|
40.2 percentage of participants
|
44.7 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after last actual dose of study drug (up to Week 72)Population: FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
SVR24 was defined as an undetectable HCV RNA Levels (\<lower limit of quantification) at 24 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL.
Outcome measures
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Prior Null Response (n = 41, 10)
|
19.5 percentage of participants
|
20.0 percentage of participants
|
|
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Prior Partial Response (n= 20, 6)
|
30.0 percentage of participants
|
16.7 percentage of participants
|
|
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Prior Relapse ( n= 21, 22)
|
61.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
Total (n= 82, 38)
|
32.9 percentage of participants
|
36.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: FA Set. Here, n signifies participants who were evaluable for specified category for each arm, respectively.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. eRVR was defined as undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
Outcome measures
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Prior Null Response (n = 41, 10)
|
24.4 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Prior Partial Response (n= 20, 6)
|
45.0 percentage of participants
|
66.7 percentage of participants
|
|
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Prior Relapse ( n= 21, 22)
|
66.7 percentage of participants
|
68.2 percentage of participants
|
|
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Total (n= 82, 38)
|
40.2 percentage of participants
|
57.9 percentage of participants
|
SECONDARY outcome
Timeframe: 4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOTPopulation: FA Set. Here number of participants analyzed signifies participants with undetectable HCV RNA (HCV RNA \<lower limit of quantification) at actual EOT and n signifies participants with undetectable HCV RNA at actual EOT for specified category.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Relapse was defined as having undetectable HCV RNA (\<lower limit of quantification) at actual end of treatment (EOT) and followed by detectable HCV RNA (\>=lower limit of quantification) during follow-up.
Outcome measures
| Measure |
Group A - Black
n=48 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=26 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Relapse
Total, 12 Wk After EOT (n=48,26)
|
18.8 percentage of participants
|
30.8 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Null Response, 4 Wk After EOT (n=17,3)
|
23.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Null Response, 12 Wk After EOT (n=17,3)
|
23.5 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Null Response, 24 Wk After EOT (n=17,3)
|
29.4 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Partial Response, 4Wk After EOT (n=13,4)
|
15.4 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Partial Response, 12 Wk After EOT (n=13,4)
|
23.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Partial Response, 24 Wk After EOT (n=13,4)
|
23.1 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Relapse, 4 Wk After EOT (n=18,19)
|
11.1 percentage of participants
|
15.8 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Relapse, 12 Wk After EOT (n=18,19)
|
11.1 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With Relapse
Prior Relapse, 24 Wk After EOT (n=18,19)
|
11.1 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With Relapse
Total, 4 Wk After EOT (n=48,26)
|
16.7 percentage of participants
|
23.1 percentage of participants
|
|
Percentage of Participants With Relapse
Total, 24 Wk After EOT (n=48,26)
|
20.8 percentage of participants
|
30.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, and 12Population: FA Set.
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Virologic breakthrough on treatment was defined as an increase of at least 1 log10 from nadir or confirmed detectable HCV RNA (\>=lower limit of quantification) after undetectable HCV RNA (\<lower limit of quantification). Percentages are calculated by using total number in FA set as denominator, in each category.
Outcome measures
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Virologic Breakthrough
Total, Week 12
|
9.8 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Null Response, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Null Response, Week 4
|
1.2 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Null Response, Week 8
|
3.7 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Null Response, Week 12
|
6.1 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Partial Response, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Partial Response, Week 4
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Partial Response, Week 8
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Partial Response, Week 12
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Relapse, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Relapse, Week 4
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Relapse, Week 8
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Prior Relapse, Week 12
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Total, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Total, Week 4
|
3.7 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With Virologic Breakthrough
Total, Week 8
|
3.7 percentage of participants
|
5.3 percentage of participants
|
SECONDARY outcome
Timeframe: Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48Population: FA Set.
On treatment virologic failure was defined as meeting any futility rule or completing assigned treatment duration and having detectable HCV RNA at EOT. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL. Futility rules: 1) Virologic breakthrough (at least 1 log10 increase from nadir or confirmed detectable HCV RNA after undetectable HCV RNA) from Day 1 through Week 24 or 48 (depending on treatment duration); 2) HCV RNA \>1000 IU/mL during Weeks 4 to 12, inclusive; 3) Detectable HCV RNA after Week 12. Percentages are calculated by using total number in FA set as denominator, in each category.
Outcome measures
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 28
|
23.2 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 28
|
6.1 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 4
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 12
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 36
|
1.2 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 12
|
18.3 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 4
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 4
|
4.9 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 8
|
8.5 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 12
|
12.2 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 16
|
19.5 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 24
|
23.2 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 36
|
25.6 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 40
|
28.0 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Null Response, Week 48
|
29.3 percentage of participants
|
13.2 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 8
|
2.4 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 12
|
4.9 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 16
|
4.9 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 24
|
6.1 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 36
|
7.3 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 40
|
7.3 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Partial Response, Week 48
|
7.3 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 2
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 8
|
0 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 16
|
1.2 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 24
|
1.2 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 28
|
1.2 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 40
|
1.2 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Prior Relapse, Week 48
|
1.2 percentage of participants
|
5.3 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 4
|
7.3 percentage of participants
|
2.6 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 8
|
11.0 percentage of participants
|
7.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 16
|
25.6 percentage of participants
|
10.5 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 24
|
30.5 percentage of participants
|
21.1 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 28
|
30.5 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 36
|
34.1 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 40
|
36.6 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants With On Treatment Virologic Failure
Total, Week 48
|
37.8 percentage of participants
|
28.9 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 52Population: Safety Set.
AE: any untoward medical occurrence in a participant during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. AE includes SAE as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event.
Outcome measures
| Measure |
Group A - Black
n=82 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 Participants
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE
|
96.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAE
|
8.5 percentage of participants
|
15.8 percentage of participants
|
SECONDARY outcome
Timeframe: up to Week 72Population: FA Set.
Sequence analysis of the HCV NS3-4A region was performed to monitor telaprevir-resistant variants. HCV RNA was isolated from the plasma, amplified by reverse transcription-polymerase chain reaction (RT-PCR), and sequenced (sequencing assay limit of detection HCV RNA \>=1000 IU/mL). Results of this outcome measure were to be reported for overall participants instead of by race and by prior response.
Outcome measures
| Measure |
Group A - Black
n=120 Participants
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
|
47 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 48 weeksPopulation: Pharmacokinetic sampling was not performed as per changes in planned analysis (protocol amendment); hence no data was collected.
Outcome measures
Outcome data not reported
Adverse Events
Group A - Black
Serious events: 7 serious events
Other events: 79 other events
Deaths: 0 deaths
Group B - Non-Black
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A - Black
n=82 participants at risk
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 participants at risk
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Warm type haemolytic anaemia
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Cellulitis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Salmonellosis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Urinary tract infection
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Vascular disorders
Accelerated hypertension
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Vascular disorders
Hypotension
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Fatigue
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Nervous system disorders
Headache
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Renal and urinary disorders
Renal failure acute
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
Other adverse events
| Measure |
Group A - Black
n=82 participants at risk
Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
Group B - Non-Black
n=38 participants at risk
Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
|
|---|---|---|
|
General disorders
Fatigue
|
37.8%
31/82 • Up to Week 52
|
68.4%
26/38 • Up to Week 52
|
|
General disorders
Influenza like illness
|
18.3%
15/82 • Up to Week 52
|
18.4%
7/38 • Up to Week 52
|
|
General disorders
Injection site erythema
|
11.0%
9/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
General disorders
Chills
|
9.8%
8/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
General disorders
Pyrexia
|
6.1%
5/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
General disorders
Injection site rash
|
4.9%
4/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
General disorders
Asthenia
|
2.4%
2/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
General disorders
Malaise
|
2.4%
2/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Oedema peripheral
|
2.4%
2/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Pain
|
0.00%
0/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
General disorders
Chest pain
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
General disorders
Adverse drug reaction
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
General disorders
Chest discomfort
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
General disorders
Crying
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
General disorders
Feeling abnormal
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Feeling jittery
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Injection site bruising
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Injection site discolouration
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
General disorders
Injection site discomfort
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
General disorders
Injection site reaction
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Local swelling
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
General disorders
Non-cardiac chest pain
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Nausea
|
24.4%
20/82 • Up to Week 52
|
44.7%
17/38 • Up to Week 52
|
|
Gastrointestinal disorders
Anal pruritus
|
19.5%
16/82 • Up to Week 52
|
13.2%
5/38 • Up to Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
7/82 • Up to Week 52
|
18.4%
7/38 • Up to Week 52
|
|
Gastrointestinal disorders
Haemorrhoids
|
9.8%
8/82 • Up to Week 52
|
13.2%
5/38 • Up to Week 52
|
|
Gastrointestinal disorders
Anorectal discomfort
|
9.8%
8/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
4.9%
4/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
3/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Gastrointestinal disorders
Dyspepsia
|
2.4%
2/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.7%
3/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.4%
2/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.7%
3/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.7%
3/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Faeces discoloured
|
1.2%
1/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Gastrointestinal disorders
Haematochezia
|
2.4%
2/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Proctalgia
|
1.2%
1/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Gastrointestinal disorders
Cheilitis
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Dry mouth
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Gingival pain
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Gastrointestinal disorders
Tongue discolouration
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Abdominal distension
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Anal fissure
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Eructation
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Frequent bowel movements
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Oral lichen planus
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
40.2%
33/82 • Up to Week 52
|
42.1%
16/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.3%
15/82 • Up to Week 52
|
34.2%
13/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.3%
6/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.3%
6/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
6.1%
5/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
6.1%
5/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Lichen planus
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Anaemia
|
48.8%
40/82 • Up to Week 52
|
50.0%
19/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.0%
9/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Nervous system disorders
Headache
|
17.1%
14/82 • Up to Week 52
|
34.2%
13/38 • Up to Week 52
|
|
Nervous system disorders
Dizziness
|
8.5%
7/82 • Up to Week 52
|
21.1%
8/38 • Up to Week 52
|
|
Nervous system disorders
Dysgeusia
|
4.9%
4/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Nervous system disorders
Disturbance in attention
|
2.4%
2/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
3/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Nervous system disorders
Paraesthesia
|
3.7%
3/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Nervous system disorders
Burning sensation
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Nervous system disorders
Lethargy
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Nervous system disorders
Neuropathy peripheral
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Nervous system disorders
Presyncope
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Nervous system disorders
Sinus headache
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Nervous system disorders
Syncope
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Nervous system disorders
Tension headache
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Nervous system disorders
Tremor
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Insomnia
|
9.8%
8/82 • Up to Week 52
|
26.3%
10/38 • Up to Week 52
|
|
Psychiatric disorders
Depression
|
9.8%
8/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Psychiatric disorders
Irritability
|
7.3%
6/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Psychiatric disorders
Anxiety
|
4.9%
4/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Psychiatric disorders
Sleep disorder
|
1.2%
1/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Psychiatric disorders
Mood swings
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Alcoholism
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Confusional state
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Initial insomnia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Psychiatric disorders
Stress
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.2%
10/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.7%
3/82 • Up to Week 52
|
18.4%
7/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.8%
8/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
5/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.9%
4/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.7%
3/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.4%
11/82 • Up to Week 52
|
18.4%
7/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
9.8%
8/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.3%
6/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Dehydration
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Sinusitis
|
4.9%
4/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Cellulitis
|
3.7%
3/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Candida infection
|
3.7%
3/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Infections and infestations
Herpes zoster
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Hordeolum
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Influenza
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Subcutaneous abscess
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Urinary tract infection
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Carbuncle
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Ear infection
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Fungal skin infection
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Furuncle
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Helicobacter gastritis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Herpes simplex
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Localised infection
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Nasopharyngitis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Oral candidiasis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Otitis externa
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Pneumonia
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Staphylococcal abscess
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Tinea infection
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.4%
11/82 • Up to Week 52
|
10.5%
4/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.5%
7/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Eye disorders
Vision blurred
|
2.4%
2/82 • Up to Week 52
|
7.9%
3/38 • Up to Week 52
|
|
Eye disorders
Abnormal sensation in eye
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Eye disorders
Eye pain
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Eye disorders
Vitreous floaters
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Eye disorders
Conjunctival haemorrhage
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Eye disorders
Dry eye
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Eye disorders
Eye pruritus
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Eye disorders
Photophobia
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Investigations
Weight decreased
|
2.4%
2/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Investigations
Blood creatinine increased
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Investigations
Cardiac murmur
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Investigations
Platelet count decreased
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Investigations
Amylase increased
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Investigations
Blood uric acid increased
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Investigations
Blood urine present
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Investigations
Haemoglobin decreased
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Investigations
Lipase increased
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.2%
1/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Laceration
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Thermal burn
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Cardiac disorders
Palpitations
|
1.2%
1/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Cardiac disorders
Angina pectoris
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Cardiac disorders
Coronary artery disease
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Cardiac disorders
Left ventricular hypertrophy
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
3.7%
3/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Reproductive system and breast disorders
Dyspareunia
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Reproductive system and breast disorders
Genital rash
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Reproductive system and breast disorders
Penile discharge
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Reproductive system and breast disorders
Penis disorder
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Vascular disorders
Hypertension
|
4.9%
4/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Vascular disorders
Flushing
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Vascular disorders
Orthostatic hypotension
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Vascular disorders
Pallor
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Ear and labyrinth disorders
Ear pain
|
2.4%
2/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/82 • Up to Week 52
|
5.3%
2/38 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell cancer of the renal pelvis and ureter
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Renal and urinary disorders
Haematuria
|
2.4%
2/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Renal and urinary disorders
Dysuria
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Endocrine disorders
Hyperthyroidism
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.2%
1/82 • Up to Week 52
|
2.6%
1/38 • Up to Week 52
|
|
Congenital, familial and genetic disorders
Haemorrhagic arteriovenous malformation
|
1.2%
1/82 • Up to Week 52
|
0.00%
0/38 • Up to Week 52
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
- Publication restrictions are in place
Restriction type: OTHER