Trial Outcomes & Findings for VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo (NCT NCT01054573)
NCT ID: NCT01054573
Last Updated: 2013-05-08
Results Overview
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of \< 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
90 participants
Primary outcome timeframe
End of trial (24 weeks after last dose, administerd at 48 weeks)
Results posted on
2013-05-08
Participant Flow
A total of 90 participants were enrolled and received treatment in the study: 9 participants from Phase 1 studies VX04-950-101 or Study VX05-950-103 and 81 participants from the Phase 3 study VX-950-TiDP24-C216 (NCT00703118) (referred to as the parent studies). The current study was conducted in 16 countries including the United States.
This study provided participants with access to telaprevir who were randomized to the control group in a previous Phase 3 study and failed therapy with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV) or to participants who received telaprevir as monotherapy or in combination with Peg-IFN-alfa-2a in 2 previous Phase 1 studies.
Participant milestones
| Measure |
Phase 1: T12(Q8h)/PR
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
Phase 3: T12(Q8h)/PR - Prior Null Responder
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
32
|
22
|
27
|
|
Overall Study
COMPLETED
|
8
|
28
|
19
|
25
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
3
|
2
|
Reasons for withdrawal
| Measure |
Phase 1: T12(Q8h)/PR
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
Phase 3: T12(Q8h)/PR - Prior Null Responder
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
2
|
1
|
Baseline Characteristics
VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo
Baseline characteristics by cohort
| Measure |
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Age Continuous
|
52 years
n=5 Participants
|
51.5 years
n=7 Participants
|
50.5 years
n=5 Participants
|
55 years
n=4 Participants
|
53 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Region of Enrollment
Europe
|
9 participants
n=5 Participants
|
18 participants
n=7 Participants
|
10 participants
n=5 Participants
|
14 participants
n=4 Participants
|
51 participants
n=21 Participants
|
|
Region of Enrollment
North America
|
0 participants
n=5 Participants
|
12 participants
n=7 Participants
|
7 participants
n=5 Participants
|
4 participants
n=4 Participants
|
23 participants
n=21 Participants
|
|
Region of Enrollment
Other
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
9 participants
n=4 Participants
|
16 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: End of trial (24 weeks after last dose, administerd at 48 weeks)Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels \< 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of \< 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
|
34.4 Percentage of participants with response
|
72.7 Percentage of participants with response
|
81.5 Percentage of participants with response
|
44.4 Percentage of participants with response
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Basline
|
0 Percentage of participants with response
|
0 Percentage of participants with response
|
0 Percentage of participants with response
|
0 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Week 48
|
43.8 Percentage of participants with response
|
72.7 Percentage of participants with response
|
85.2 Percentage of participants with response
|
77.8 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Week 4
|
37.5 Percentage of participants with response
|
77.3 Percentage of participants with response
|
85.2 Percentage of participants with response
|
33.3 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Week 8
|
56.3 Percentage of participants with response
|
86.4 Percentage of participants with response
|
92.6 Percentage of participants with response
|
66.7 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Week 12
|
59.4 Percentage of participants with response
|
90.9 Percentage of participants with response
|
92.6 Percentage of participants with response
|
66.7 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Week 24
|
50.0 Percentage of participants with response
|
77.3 Percentage of participants with response
|
85.2 Percentage of participants with response
|
66.7 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Week 36
|
43.8 Percentage of participants with response
|
81.8 Percentage of participants with response
|
85.2 Percentage of participants with response
|
77.8 Percentage of participants with response
|
|
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
End of Treatment
|
43.8 Percentage of participants with response
|
86.4 Percentage of participants with response
|
92.6 Percentage of participants with response
|
77.8 Percentage of participants with response
|
SECONDARY outcome
Timeframe: Week 4, Week 8Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value \>100 IU/mL.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
|
28.1 Percentage of participants
|
4.5 Percentage of participants
|
3.7 Percentage of participants
|
11.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12 or Weeks 24 or 36Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of \>100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of \>=25 IU/mL.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Week 12
|
31.2 Percentage of participants
|
4.5 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Week 24
|
9.4 Percentage of participants
|
9.1 Percentage of participants
|
3.7 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Week 36
|
9.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA values of \<25 IU/mL, target not detected at Week 4 of treatment).
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Rapid Virologic Response (RVR)
|
37.5 Percentage of participants
|
77.3 Percentage of participants
|
85.2 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 4 and 12Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA values of \<25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
|
34.4 Percentage of participants
|
72.7 Percentage of participants
|
85.2 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase \>1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is \> 25 IU/mL, or a confirmed value of HCV RNA \>100 IU/mL in participants whose HCV RNA had previously become \<25 IU/mL (detected or target not detected) during the considered treatment phase.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Percentage of Participants With Viral Breakthrough
Week 48 (Period After Telaprevir Intake)
|
25.0 Percentage of participants
|
9.1 Percentage of participants
|
3.7 Percentage of participants
|
11.1 Percentage of participants
|
|
Percentage of Participants With Viral Breakthrough
Week 12 (Telaprevir Treatment Phase)
|
15.6 Percentage of participants
|
4.5 Percentage of participants
|
0.0 Percentage of participants
|
11.1 Percentage of participants
|
SECONDARY outcome
Timeframe: During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)Population: The analysis was performed on the full analysis (FA) set, which included all randomized participants who received at least one dose of study drug and had data at the follow-up visit performed 24 weeks after the last dose of study drug.
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] during the 24-week follow-up period after previous HCV RNA \<25 IU/mL, target not detected, at end of treatment).
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=14 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=19 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=25 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=7 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Percentage of Participants Who Relapsed During Follow-Up
|
21.4 Percentage of participants
|
5.3 Percentage of participants
|
4.0 Percentage of participants
|
28.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, 48Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Week 4 (n=32, 22, 26, and 9)
|
1.24 Log 10 IU/mL
Interval 0.7 to 6.7
|
0.70 Log 10 IU/mL
Interval 0.7 to 1.2
|
0.70 Log 10 IU/mL
Interval 0.7 to 2.3
|
1.24 Log 10 IU/mL
Interval 0.7 to 1.5
|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Baseline (n=32, 22, 27, and 9)
|
6.63 Log 10 IU/mL
Interval 5.2 to 7.3
|
6.72 Log 10 IU/mL
Interval 5.6 to 7.3
|
6.48 Log 10 IU/mL
Interval 5.3 to 7.5
|
6.76 Log 10 IU/mL
Interval 6.0 to 7.2
|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Week 8 (n=32, 22, 26, and 9)
|
0.70 Log 10 IU/mL
Interval 0.7 to 6.9
|
0.70 Log 10 IU/mL
Interval 0.7 to 2.7
|
0.70 Log 10 IU/mL
Interval 0.7 to 1.6
|
0.70 Log 10 IU/mL
Interval 0.7 to 2.9
|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Week 12 (n=31, 22, 26, and 9)
|
0.70 Log 10 IU/mL
Interval 0.7 to 7.1
|
0.70 Log 10 IU/mL
Interval 0.7 to 4.3
|
0.70 Log 10 IU/mL
Interval 0.7 to 1.2
|
0.70 Log 10 IU/mL
Interval 0.7 to 5.5
|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Week 24 (n=23, 20, 26, and 8)
|
0.70 Log 10 IU/mL
Interval 0.7 to 6.6
|
0.70 Log 10 IU/mL
Interval 0.7 to 4.8
|
0.70 Log 10 IU/mL
Interval 0.7 to 2.1
|
0.70 Log 10 IU/mL
Interval 0.7 to 6.2
|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Week 36 (n=18, 19, 23, and 7)
|
0.70 Log 10 IU/mL
Interval 0.7 to 4.8
|
0.70 Log 10 IU/mL
Interval 0.7 to 4.8
|
0.70 Log 10 IU/mL
Interval 0.7 to 0.7
|
0.70 Log 10 IU/mL
Interval 0.7 to 0.7
|
|
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Week 48 (n=16, 16, 21, and 7)
|
0.70 Log 10 IU/mL
Interval 0.7 to 2.3
|
0.70 Log 10 IU/mL
Interval 0.7 to 0.7
|
0.70 Log 10 IU/mL
Interval 0.7 to 0.7
|
0.70 Log 10 IU/mL
Interval 0.7 to 0.7
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 8, 12, 24, 36, and 48Population: All analyses were performed on the full analysis (FA) set, which was defined as all randomized participants who received at least one dose of study drug.
The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.
Outcome measures
| Measure |
Phase 3: T12(Q8h)/PR - Prior Null Responder
n=32 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
|
Phase 3: T12(Q8h)/PR - Prior Partial Responder
n=22 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
|
Phase 3: T12(Q8h)/PR - Prior Relapser
n=27 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
|
Phase 1: T12(Q8h)/PR
n=9 Participants
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
|---|---|---|---|---|
|
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Week 8 (n=32, 22, 26, and 9)
|
-5.51 log 10 IU/ml
Interval -6.6 to -0.4
|
-5.88 log 10 IU/ml
Interval -6.6 to -4.6
|
-5.62 log 10 IU/ml
Interval -6.8 to -4.6
|
-5.96 log 10 IU/ml
Interval -6.3 to -3.4
|
|
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Week 12 (n=31, 22, 26, 9)
|
-5.40 log 10 IU/ml
Interval -6.6 to -0.2
|
-5.88 log 10 IU/ml
Interval -6.6 to -3.0
|
-5.62 log 10 IU/ml
Interval -6.8 to -4.6
|
-5.96 log 10 IU/ml
Interval -6.3 to -0.9
|
|
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Week 36 (n=18, 19, 23, and 7)
|
-5.95 log 10 IU/ml
Interval -6.6 to -0.6
|
-5.86 log 10 IU/ml
Interval -6.6 to -2.3
|
-5.78 log 10 IU/ml
Interval -6.8 to -4.6
|
-6.07 log 10 IU/ml
Interval -6.3 to -5.3
|
|
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Week 48 (n=15, 16, 21, and 7)
|
-6.03 log 10 IU/ml
Interval -6.6 to -4.1
|
-5.88 log 10 IU/ml
Interval -6.6 to -5.2
|
-5.71 log 10 IU/ml
Interval -6.8 to -4.6
|
-6.07 log 10 IU/ml
Interval -6.3 to -5.3
|
|
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Week 4 (n=32, 22, 26, and 9)
|
-5.39 log 10 IU/ml
Interval -6.6 to -0.6
|
-5.83 log 10 IU/ml
Interval -6.6 to -4.9
|
-5.59 log 10 IU/ml
Interval -6.8 to -4.4
|
-5.55 log 10 IU/ml
Interval -6.1 to -5.1
|
|
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Week 24 (n=23, 20, 24, and 8)
|
-5.89 log 10 IU/ml
Interval -6.6 to 1.0
|
-5.72 log 10 IU/ml
Interval -6.6 to -2.2
|
-5.75 log 10 IU/ml
Interval -6.8 to -4.6
|
-5.87 log 10 IU/ml
Interval -6.1 to -1.0
|
Adverse Events
Phase 1: T12(Q8h)/PR
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 3: T12(Q8h)/PR
Serious events: 5 serious events
Other events: 77 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1: T12(Q8h)/PR
n=9 participants at risk
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
Phase 3: T12(Q8h)/PR
n=81 participants at risk
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
3.7%
3/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
Other adverse events
| Measure |
Phase 1: T12(Q8h)/PR
n=9 participants at risk
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
|
Phase 3: T12(Q8h)/PR
n=81 participants at risk
T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
|
|---|---|---|
|
Gastrointestinal disorders
Haemorrhoids
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
11.1%
9/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Nausea
|
55.6%
5/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
22.2%
18/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
General disorders
Asthenia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
18.5%
15/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
General disorders
Fatigue
|
77.8%
7/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
40.7%
33/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Blood and lymphatic system disorders
Anaemia
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
28.4%
23/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
9.9%
8/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
13.6%
11/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
8.6%
7/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Ear and labyrinth disorders
Vertigo
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Eye disorders
Dry eye
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
7.4%
6/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
7.4%
6/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
14.8%
12/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
General disorders
Influenza like illness
|
33.3%
3/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
9.9%
8/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
General disorders
Irritability
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
12.3%
10/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
General disorders
Mucosal inflammation
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
General disorders
Pyrexia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
13.6%
11/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Infections and infestations
Bronchitis
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Infections and infestations
Fungal infection
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
2.5%
2/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
2.5%
2/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Investigations
Weight decreased
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
14.8%
12/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
22.2%
2/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
8.6%
7/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Nervous system disorders
Disturbance in attention
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
2.5%
2/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
11.1%
9/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
21.0%
17/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Psychiatric disorders
Depression
|
33.3%
3/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
7.4%
6/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
14.8%
12/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Reproductive system and breast disorders
Genital rash
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
11.1%
9/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
3/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
11.1%
9/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
6.2%
5/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
22.2%
2/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
11.1%
9/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
0.00%
0/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
40.7%
33/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
3/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
21.0%
17/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
|
Vascular disorders
Hypertension
|
11.1%
1/9 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
1.2%
1/81 • From Baseline (Day 1) through Week 48 (or last dose of study drug received) + 24 week follow-up period.
|
Additional Information
Medical Leader
Janssen Research & Development, LLC
Phone: 1 609 730-3174
Results disclosure agreements
- Principal investigator is a sponsor employee It is the policy of the sponsor not to allow the investigators to publish their results or findings prior to the sponsor's publication of the overall trial results. The investigator agrees that before he/she publishes any results of this trial, he/she shall allow at least 45 days for the sponsor to review the prepublication manuscript prior to submission of the manuscript to the publisher as specified in the Clinical Trial Agreement between institution/investigator and sponsor.
- Publication restrictions are in place
Restriction type: OTHER