An Open-Label Study of the Effect of Telaprevir in Combin... | NCT01701063

Name	Class
Janssen Pharmaceuticals	INDUSTRY

Label	Type	Description	Intervention Names
Treatment-Naive or Prior Partial/Null Response	Experimental	telaprevir + Peginterferon alfa-2b + Ribavirin	Drug: Telaprevir Drug: Peginterferon alfa-2b Drug: Ribavirin

Name	Type	Description	Arm Group Labels	Other Names
Telaprevir	Drug	100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration	Treatment-Naive or Prior Partial/Null Response

Measure	Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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.	Baseline up to Week 52

Measure	Description	Time Frame
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)	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).

Name	Affiliation	Role
Medical Monitor	Vertex Pharmaceuticals Incorporated	Study Director

ID	Title	Description
FG000	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.

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

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.

Safety set included all participants who received at least 1 dose of study drug.

Posted

Number

participants

Baseline up to Week 52

ID	Title	Description
OG000	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 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.
OG001	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.
OG002	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.

Units	Counts
Participants	OG00013 OG00119 OG00210

Title

Denominators

Categories

Participants with SAEs

Title	Measurements
	OG0000 OG0010 OG0021

Participants with AEs

Secondary

Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)

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).

Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

12 weeks after last planned dose of study drug (up to Week 60)

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)

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.

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).

Posted

24 weeks after last planned dose of study drug (up to Week 72)

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With Rapid Virologic Response (RVR)

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 (\

FAS included all enrolled participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 4

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With Extended Rapid Virologic Response (eRVR)

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 (\

FAS included all enrolled participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 4 and Week 12

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With Undetectable HCV RNA at Week 12

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.

FAS included all enrolled participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Week 12

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With On-treatment Virologic Failure

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.

FAS included all enrolled participants who received at least 1 dose of study drug.

Posted

Number

percentage of participants

Baseline up to Week 48

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Percentage of Participants With Virologic Relapse

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.

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.

Posted

Number

percentage of participants

12 weeks after planned EOT (up to Week 60)

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region

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.

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.

Posted

Number

participants

Baseline, On treatment (up to Week 48)

ID	Title	Description
OG000	Overall Participants	Participants aged 3 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 to 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.

Units	Counts

Secondary

Maximum Plasma Concentration (Cmax) of Telaprevir

Cmax was measured for telaprevir only.

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.

Posted

Mean

Standard Deviation

nanogram per milliliter (ng/mL)

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 7

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir

Tmax was measured for telaprevir only.

PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Posted

Median

Full Range

hours (h)

ID	Title	Description
OG000	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 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.
OG001	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.

Secondary

Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir

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.

PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

hours*nanogram per milliliter (h*ng/mL)

ID	Title	Description
OG000	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 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.

Secondary

Elimination Half-Life (T1/2) of Telaprevir

T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.

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.

Posted

ID	Title	Description
OG000	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 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.
OG001	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.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Vomiting	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG00013 events8 affected13 at risk EG00123 events12 affected19 at risk EG00212 events6 affected10 at risk
Nausea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0009 events7 affected13 at risk EG0019 events5 affected19 at risk EG00214 events5 affected10 at risk
Anal pruritus	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0006 events4 affected13 at risk EG0015 events4 affected19 at risk EG0023 events3 affected10 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0005 events5 affected13 at risk EG0019 events3 affected19 at risk EG0021 events1 affected10 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0016 events5 affected19 at risk EG0020 events0 affected10 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0016 events3 affected19 at risk EG0020 events0 affected10 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Anal fissure	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Aphthous stomatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Cheilitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Constipation	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Diarrhoea haemorrhagic	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Gingival pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Lip ulceration	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Oral disorder	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Oral pain	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Stomatitis	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Tooth impacted	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Toothache	Gastrointestinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Pyrexia	General disorders	MedDRA 18.0	Systematic Assessment	EG00035 events7 affected13 at risk EG00138 events11 affected19 at risk EG00275 events8 affected10 at risk
Fatigue	General disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected13 at risk EG00111 events5 affected19 at risk EG0027 events3 affected10 at risk
Pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0006 events2 affected13 at risk EG0018 events4 affected19 at risk EG00223 events5 affected10 at risk
Injection site erythema	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected13 at risk EG0012 events2 affected19 at risk EG0025 events3 affected10 at risk
Influenza like illness	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0013 events2 affected19 at risk EG0022 events1 affected10 at risk
Chills	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected19 at risk EG0022 events1 affected10 at risk
Discomfort	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected13 at risk EG00110 events2 affected19 at risk EG0020 events0 affected10 at risk
Injection site pruritus	General disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Injection site rash	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Malaise	General disorders	MedDRA 18.0	Systematic Assessment	EG0004 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Non-cardiac chest pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Product taste abnormal	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected19 at risk EG0020 events0 affected10 at risk
Injection site bruising	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected19 at risk EG0020 events0 affected10 at risk
Injection site reaction	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Peripheral swelling	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Temperature intolerance	General disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Vessel puncture site pain	General disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Headache	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG00031 events8 affected13 at risk EG00179 events16 affected19 at risk EG00212 events6 affected10 at risk
Dizziness	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0007 events5 affected13 at risk EG0016 events5 affected19 at risk EG0020 events0 affected10 at risk
Lethargy	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Paraesthesia	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected19 at risk EG0020 events0 affected10 at risk
Presyncope	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Somnolence	Nervous system disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected13 at risk EG00110 events5 affected19 at risk EG0023 events3 affected10 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 events4 affected13 at risk EG0012 events2 affected19 at risk EG0026 events3 affected10 at risk
Alopecia	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0007 events7 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Pruritus generalised	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0018 events3 affected19 at risk EG0020 events0 affected10 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0022 events2 affected10 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0014 events1 affected19 at risk EG0020 events0 affected10 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Cold sweat	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Eczema	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Skin irritation	Skin and subcutaneous tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events1 affected19 at risk EG0020 events0 affected10 at risk
Oral herpes	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected19 at risk EG0021 events1 affected10 at risk
Bronchitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Pharyngitis streptococcal	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0022 events2 affected10 at risk
Sinusitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Urinary tract infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Conjunctivitis bacterial	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Ear infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Gastroenteritis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Hordeolum	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Nasopharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Parvovirus infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Pharyngitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Pneumonia	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Rash pustular	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Skin infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Tinea infection	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Tonsillitis	Infections and infestations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0006 events4 affected13 at risk EG0015 events5 affected19 at risk EG0021 events1 affected10 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0004 events4 affected13 at risk EG0015 events3 affected19 at risk EG0022 events2 affected10 at risk
Leukopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0015 events4 affected19 at risk EG0021 events1 affected10 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0003 events3 affected13 at risk EG0016 events5 affected19 at risk EG0023 events3 affected10 at risk
Abnormal loss of weight	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Hypercholesterolaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Hyperinsulinaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Insomnia	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0012 events1 affected19 at risk EG0021 events1 affected10 at risk
Depression	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0012 events2 affected19 at risk EG0020 events0 affected10 at risk
Affect lability	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0022 events2 affected10 at risk
Mood altered	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected19 at risk EG0020 events0 affected10 at risk
Mood swings	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Agitation	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Anxiety	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Flat affect	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Restlessness	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Sleep terror	Psychiatric disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0013 events2 affected19 at risk EG0025 events2 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0013 events2 affected19 at risk EG0021 events1 affected10 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0003 events2 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0022 events1 affected10 at risk
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Rhinitis allergic	Respiratory, thoracic and mediastinal disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Blood bicarbonate decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Blood triglycerides increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0012 events2 affected19 at risk EG0020 events0 affected10 at risk
Blood uric acid increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0021 events1 affected10 at risk
Weight decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0002 events1 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Alanine aminotransferase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Blood bilirubin increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Body temperature increased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Haemoglobin decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Neutrophil count decreased	Investigations	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0013 events2 affected19 at risk EG0020 events0 affected10 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0006 events2 affected13 at risk EG0012 events2 affected19 at risk EG0020 events0 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0012 events2 affected19 at risk EG0020 events0 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Excoriation	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Eye irritation	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0011 events1 affected19 at risk EG0020 events0 affected10 at risk
Eye pain	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Eye pruritus	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Mydriasis	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Vision blurred	Eye disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Seasonal allergy	Immune system disorders	MedDRA 18.0	Systematic Assessment	EG0002 events2 affected13 at risk EG0010 events0 affected19 at risk EG0026 events2 affected10 at risk
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0013 events1 affected19 at risk EG0020 events0 affected10 at risk
Amenorrhoea	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Oligomenorrhoea	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Pruritus genital	Reproductive system and breast disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk
Flushing	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Pallor	Vascular disorders	MedDRA 18.0	Systematic Assessment	EG0001 events1 affected13 at risk EG0010 events0 affected19 at risk EG0020 events0 affected10 at risk
Ear pain	Ear and labyrinth disorders	MedDRA 18.0	Systematic Assessment	EG0000 events0 affected13 at risk EG0010 events0 affected19 at risk EG0021 events1 affected10 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Phoenix	Arizona		United States

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human
D014777	Virus Diseases
D018178	Flaviviridae Infections
D012327	RNA Virus Infections
D006505	Hepatitis
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D012263	Ribonucleosides
D009705	Nucleosides
D009706	Nucleic Acids, Nucleotides, and Nucleosides

ID	Title	Description
BG000	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 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.
BG001	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.
BG002	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.
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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 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.	0	13	13	13
EG001	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.	0	19	18	19
EG002	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.	1	10	10	10

ID	Term
C486464	telaprevir
C417083	peginterferon alfa-2b
D012254	Ribavirin