Trial Outcomes & Findings for An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus (NCT NCT01701063)
NCT ID: NCT01701063
Last Updated: 2016-07-20
Results Overview
AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: 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. "Study drug" includes all investigational agents administered during the course of the study.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Baseline up to Week 52
Results posted on
2016-07-20
Participant Flow
The study was planned to be conducted in 2 parts (Part A and Part B), which would use separate groups of participants. However, the study was terminated early (12 weeks after last dose of study drug in Part A) and Part B was not conducted.
Participant milestones
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram \[mg/kg\] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m\^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Overall Study
STARTED
|
13
|
19
|
10
|
|
Overall Study
COMPLETED
|
13
|
18
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram \[mg/kg\] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m\^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
1
|
|
Overall Study
Other
|
0
|
0
|
1
|
Baseline Characteristics
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
Baseline characteristics by cohort
| Measure |
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Total
n=42 Participants
Total of all reporting groups
|
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|---|
|
Age, Continuous
|
4.9 years
STANDARD_DEVIATION 0.88 • n=5 Participants
|
10.4 years
STANDARD_DEVIATION 4.05 • n=4 Participants
|
14.9 years
STANDARD_DEVIATION 2.06 • n=5 Participants
|
10.2 years
STANDARD_DEVIATION 1.57 • n=7 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: Safety set included all participants who received at least 1 dose of study drug.
AE: any adverse change from the participant's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: 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. "Study drug" includes all investigational agents administered during the course of the study.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with SAEs
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Participants with AEs
|
13 participants
|
18 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 12 weeks after last planned dose of study drug (up to Week 60)Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (less than \[\<\] lower limit of quantification) at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/High Pure System (HPS) RNA assay version 2.0. The lower limit of quantification was 25 international units per milliliter (IU/mL).
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
|
69.2 percentage of participants
|
89.5 percentage of participants
|
40.0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 weeks after last planned dose of study drug (up to Week 72)Population: SVR24 was not analyzed because study was terminated early and follow-up was conducted only up to 12 weeks after planned end of treatment (EOT).
SVR24 was defined as an undetectable HCV RNA Levels (\< lower limit of quantification) at 24 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4Population: FAS included all enrolled participants who received at least 1 dose of study drug.
The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. RVR was defined as an undetectable HCV RNA (\<lower limit of quantification) 4 weeks after the start of study treatment.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
69.2 percentage of participants
|
73.7 percentage of participants
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4 and Week 12Population: FAS included all enrolled participants who received at least 1 dose of study drug.
The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL. eRVR was defined as an undetectable HCV RNA (\<lower limit of quantification) at both 4 weeks and 12 weeks after the start of study treatment.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
|
61.5 percentage of participants
|
73.7 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: FAS included all enrolled participants who received at least 1 dose of study drug.
The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay version 2.0. The lower limit of quantification was 25 IU/mL.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Percentage of Participants With Undetectable HCV RNA at Week 12
|
69.2 percentage of participants
|
89.5 percentage of participants
|
70.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 48Population: FAS included all enrolled participants who received at least 1 dose of study drug.
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 COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Futility rules: 1) HCV RNA \>1000 IU/mL at Week 4; 2) HCV RNA \>1000 IU/mL at Week 12; 3) Detectable HCV RNA after Week 12 to end of treatment.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Percentage of Participants With On-treatment Virologic Failure
|
15.4 percentage of participants
|
5.3 percentage of participants
|
30.0 percentage of participants
|
SECONDARY outcome
Timeframe: 12 weeks after planned EOT (up to Week 60)Population: FAS included all enrolled participants who received at least 1 dose of study drug. Here 'Number of Participants Analyzed' signifies those participants who completed the assigned treatment period and had undetectable HCV RNA at EOT.
The plasma HCV RNA level was measured using Roche COBAS TaqMan HCV/HPS RNA assay Version 2.0. The lower limit of quantification was 25 IU/mL. Viral relapse was defined as having detectable HCV at follow-up in participants who had HCV RNA less than (\<) lower limit of quantification (LLOQ) at planned EOT.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=9 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=17 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=7 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Percentage of Participants With Virologic Relapse
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, On treatment (up to Week 48)Population: FAS. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome and 'n' signifies those who were evaluable at the specified time point.
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 age.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=41 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
Baseline (n = 41)
|
2 participants
|
—
|
—
|
|
Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
On treatment (n = 6)
|
6 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7Population: Pharmacokinetic (PK) population included all participants who received at least a single dose of telaprevir, whether the participant completed all treatments or not. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Cmax was measured for telaprevir only.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=9 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Maximum Plasma Concentration (Cmax) of Telaprevir
|
4310 nanogram per milliliter (ng/mL)
Standard Deviation 1160
|
5050 nanogram per milliliter (ng/mL)
Standard Deviation 884
|
4060 nanogram per milliliter (ng/mL)
Standard Deviation 1500
|
SECONDARY outcome
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7Population: PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Tmax was measured for telaprevir only.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=9 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir
|
4.00 hours (h)
Interval 1.92 to 8.0
|
4.00 hours (h)
Interval 1.98 to 6.02
|
4.00 hours (h)
Interval 1.5 to 8.0
|
SECONDARY outcome
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7Population: PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
AUC was measured for telaprevir only. AUC 0-t last was defined as the area under the concentration-time curve from the time of dosing to the last measurable concentration. AUC 0-12 hour (AUC 0-12h) was calculated by respecifying predose concentrations as 12 hour concentrations. AUC 0-24h was calculated as AUC 0-12h multiplied by 2. Dose adjusted AUC (AUC 0-24h\_Adj) was calculated by multiplying AUC 0-24h by the dose adjustment factor to obtain projected exposures in participants who were misdosed. Data were presented for AUC 0-t last, AUC 0-12h, AUC 0-24h, AUC 0-24h\_Adj.
Outcome measures
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 Participants
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=9 Participants
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
AUC 0-t last
|
39900 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 11300
|
43300 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 9480
|
35300 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 12000
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
AUC 0-12h
|
39900 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 11300
|
44100 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 9020
|
35300 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 12000
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
AUC 0-24h
|
79900 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 22700
|
88100 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 18000
|
70600 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 24100
|
|
Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
AUC 0-24h_Adj
|
95700 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 29800
|
88600 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 19200
|
76300 hours*nanogram per milliliter (h*ng/mL)
Standard Deviation 22800
|
SECONDARY outcome
Timeframe: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7Population: Half life was not calculated because the calculation required the slope of terminal elimination phase and the PK sampling was relatively sparse and did not yield a terminal elimination phase from which half-life can be accurately estimated.
T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 participants at risk
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 participants at risk
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 participants at risk
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Infections and infestations
Infection
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
Other adverse events
| Measure |
Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=13 participants at risk
Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=19 participants at risk
Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
n=10 participants at risk
Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m\^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
|
|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
61.5%
8/13 • Number of events 13 • Baseline up to Week 52
|
63.2%
12/19 • Number of events 23 • Baseline up to Week 52
|
60.0%
6/10 • Number of events 12 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Nausea
|
53.8%
7/13 • Number of events 9 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 9 • Baseline up to Week 52
|
50.0%
5/10 • Number of events 14 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Anal pruritus
|
30.8%
4/13 • Number of events 6 • Baseline up to Week 52
|
21.1%
4/19 • Number of events 5 • Baseline up to Week 52
|
30.0%
3/10 • Number of events 3 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain
|
38.5%
5/13 • Number of events 5 • Baseline up to Week 52
|
15.8%
3/19 • Number of events 9 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Abdominal pain upper
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 6 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Diarrhoea
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
15.8%
3/19 • Number of events 6 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Abdominal distension
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Anorectal discomfort
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
7.7%
1/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Lip ulceration
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Oral pain
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Tooth impacted
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Pyrexia
|
53.8%
7/13 • Number of events 35 • Baseline up to Week 52
|
57.9%
11/19 • Number of events 38 • Baseline up to Week 52
|
80.0%
8/10 • Number of events 75 • Baseline up to Week 52
|
|
General disorders
Fatigue
|
53.8%
7/13 • Number of events 7 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 11 • Baseline up to Week 52
|
30.0%
3/10 • Number of events 7 • Baseline up to Week 52
|
|
General disorders
Pain
|
15.4%
2/13 • Number of events 6 • Baseline up to Week 52
|
21.1%
4/19 • Number of events 8 • Baseline up to Week 52
|
50.0%
5/10 • Number of events 23 • Baseline up to Week 52
|
|
General disorders
Injection site erythema
|
23.1%
3/13 • Number of events 3 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
30.0%
3/10 • Number of events 5 • Baseline up to Week 52
|
|
General disorders
Influenza like illness
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 3 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 2 • Baseline up to Week 52
|
|
General disorders
Chills
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 2 • Baseline up to Week 52
|
|
General disorders
Discomfort
|
7.7%
1/13 • Number of events 2 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 10 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Injection site pruritus
|
7.7%
1/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
General disorders
Injection site rash
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Malaise
|
15.4%
2/13 • Number of events 4 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Non-cardiac chest pain
|
15.4%
2/13 • Number of events 3 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Product taste abnormal
|
0.00%
0/13 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Injection site bruising
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Injection site reaction
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Peripheral swelling
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Temperature intolerance
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Nervous system disorders
Headache
|
61.5%
8/13 • Number of events 31 • Baseline up to Week 52
|
84.2%
16/19 • Number of events 79 • Baseline up to Week 52
|
60.0%
6/10 • Number of events 12 • Baseline up to Week 52
|
|
Nervous system disorders
Dizziness
|
38.5%
5/13 • Number of events 7 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 6 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Nervous system disorders
Lethargy
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
23.1%
3/13 • Number of events 3 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 10 • Baseline up to Week 52
|
30.0%
3/10 • Number of events 3 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash
|
30.8%
4/13 • Number of events 6 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
30.0%
3/10 • Number of events 6 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
53.8%
7/13 • Number of events 7 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
15.8%
3/19 • Number of events 8 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
20.0%
2/10 • Number of events 2 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 4 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Oral herpes
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Bronchitis
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
20.0%
2/10 • Number of events 2 • Baseline up to Week 52
|
|
Infections and infestations
Sinusitis
|
15.4%
2/13 • Number of events 3 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Urinary tract infection
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Ear infection
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Hordeolum
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Parvovirus infection
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Pharyngitis
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Pneumonia
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Rash pustular
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Infections and infestations
Skin infection
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Tinea infection
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Infections and infestations
Tonsillitis
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
4/13 • Number of events 6 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 5 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.8%
4/13 • Number of events 4 • Baseline up to Week 52
|
15.8%
3/19 • Number of events 5 • Baseline up to Week 52
|
20.0%
2/10 • Number of events 2 • Baseline up to Week 52
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
21.1%
4/19 • Number of events 5 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.1%
3/13 • Number of events 3 • Baseline up to Week 52
|
26.3%
5/19 • Number of events 6 • Baseline up to Week 52
|
30.0%
3/10 • Number of events 3 • Baseline up to Week 52
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Metabolism and nutrition disorders
Dehydration
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Metabolism and nutrition disorders
Hyperinsulinaemia
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 2 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
20.0%
2/10 • Number of events 2 • Baseline up to Week 52
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/13 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Psychiatric disorders
Mood swings
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Psychiatric disorders
Agitation
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Psychiatric disorders
Flat affect
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Psychiatric disorders
Sleep terror
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 3 • Baseline up to Week 52
|
20.0%
2/10 • Number of events 5 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/13 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 3 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.4%
2/13 • Number of events 3 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 2 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Blood bicarbonate decreased
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/13 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Blood uric acid increased
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Investigations
Weight decreased
|
7.7%
1/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Blood bilirubin increased
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Body temperature increased
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Investigations
Haemoglobin decreased
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 3 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
15.4%
2/13 • Number of events 6 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
10.5%
2/19 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Injury, poisoning and procedural complications
Contusion
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Injury, poisoning and procedural complications
Excoriation
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Eye disorders
Eye irritation
|
0.00%
0/13 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Eye disorders
Eye pain
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Eye disorders
Eye pruritus
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Eye disorders
Mydriasis
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Eye disorders
Vision blurred
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Immune system disorders
Seasonal allergy
|
15.4%
2/13 • Number of events 2 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
20.0%
2/10 • Number of events 6 • Baseline up to Week 52
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
5.3%
1/19 • Number of events 3 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Reproductive system and breast disorders
Amenorrhoea
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Reproductive system and breast disorders
Oligomenorrhoea
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline up to Week 52
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Vascular disorders
Pallor
|
7.7%
1/13 • Number of events 1 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
0.00%
0/10 • Baseline up to Week 52
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/13 • Baseline up to Week 52
|
0.00%
0/19 • Baseline up to Week 52
|
10.0%
1/10 • Number of events 1 • Baseline 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