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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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Terminated
CT.gov ID
NCT01701063
Collaborator
Janssen Pharmaceuticals (Industry)
42
Enrollment
24
Locations
1
Arm
26.9
Duration (Months)
1.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose adjustments if needed before Part B.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Two-Part, Open-Label, Single-Arm Phase 1/2 Study of Safety, Pharmacokinetics, and Efficacy of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Aged 3 to 17 Infected With Genotype 1 Hepatitis C Virus
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Apr 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment-Naive or Prior Partial/Null Response

telaprevir + Peginterferon alfa-2b + Ribavirin

Drug: Telaprevir
100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration

Drug: Peginterferon alfa-2b
50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection
Other Names:
  • PegIntron®

    • Drug: Ribavirin
    200-mg capsules or 40-mg/mL solution for oral administration
    Other Names:
  • Rebetol®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to Week 52]

      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.

    Secondary Outcome Measures

    1. Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) [12 weeks after last planned dose of study drug (up to Week 60)]

      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).

    2. Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24) [24 weeks after last planned dose of study drug (up to Week 72)]

      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.

    3. Percentage of Participants With Rapid Virologic Response (RVR) [Week 4]

      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.

    4. Percentage of Participants With Extended Rapid Virologic Response (eRVR) [Week 4 and 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. 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.

    5. Percentage of Participants With Undetectable HCV RNA at Week 12 [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.

    6. Percentage of Participants With On-treatment Virologic Failure [Baseline up to Week 48]

      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.

    7. Percentage of Participants With Virologic Relapse [12 weeks after planned EOT (up to Week 60)]

      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.

    8. Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region [Baseline, On treatment (up to Week 48)]

      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.

    9. Maximum Plasma Concentration (Cmax) of Telaprevir [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]

      Cmax was measured for telaprevir only.

    10. Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir [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]

      Tmax was measured for telaprevir only.

    11. Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir [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]

      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.

    12. Elimination Half-Life (T1/2) of Telaprevir [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]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Males or females ages 3 to 17 years of age

    • Chronic hepatitis C

    • Hepatitis C virus genotype 1a or b at the Screening Visit

    • Subject is judged to be in good health (besides HCV infection) in the opinion of the investigator.

    • Signed informed consent form (ICF), and where appropriate, signed Assent Form

    Exclusion Criteria:

    • History of or prior evidence of a medical condition associated with chronic liver disease other than HCV

    • Body weight <15 kg or >90 kg

    • Prior evidence of hepatic decompensation

    • Contraindications to pegylated interferon/ribavirin (Peg-IFN/RBV)

    • History or other evidence of severe retinopathy or clinically significant ophthalmological disorder

    • History of non-genotype 1 HCV

    • Participation in investigational drug study as described in Study Protocol

    • Use of prohibited drugs within 7 days or 5 half-lives before the first dose of study drug

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Phoenix Arizona United States
    2 San Francisco California United States
    3 Denver Colorado United States
    4 Washington District of Columbia United States
    5 Gainesville Florida United States
    6 Miami Florida United States
    7 Indianapolis Indiana United States
    8 Baltimore Maryland United States
    9 Bronx New York United States
    10 New York New York United States
    11 Philadelphia Pennsylvania United States
    12 Houston Texas United States
    13 Seattle Washington United States
    14 Brussel Belgium
    15 Bruxelles Belgium
    16 Wuppertal Germany
    17 Milano Italy
    18 Padova Italy
    19 Pisa Italy
    20 Esplugues de Llobregat Spain
    21 Madrid Spain
    22 Birmingham United Kingdom
    23 Leeds United Kingdom
    24 London United Kingdom

    Sponsors and Collaborators

    • Vertex Pharmaceuticals Incorporated
    • Janssen Pharmaceuticals

    Investigators

    • Study Director: Medical Monitor, Vertex Pharmaceuticals Incorporated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01701063
    Other Study ID Numbers:
    • VX11-950-118
    First Posted:
    Oct 4, 2012
    Last Update Posted:
    Jul 20, 2016
    Last Verified:
    Apr 1, 2016
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Ribavirin
    Peginterferon alfa-2b

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail 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.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Period Title: Overall Study
    STARTED 13 19 10
    COMPLETED 13 18 8
    NOT COMPLETED 0 1 2

    Baseline Characteristics

    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Total
    Arm/Group Description 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. 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. 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 of all reporting groups
    Overall Participants 13 19 10 42
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    14.9
    (2.06)
    10.2
    (1.57)
    4.9
    (0.88)
    10.4
    (4.05)
    Sex: Female, Male (Count of Participants)
    Female
    11
    84.6%
    13
    68.4%
    4
    40%
    28
    66.7%
    Male
    2
    15.4%
    6
    31.6%
    6
    60%
    14
    33.3%

    Outcome Measures

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

    Outcome Measure Data

    Analysis Population Description
    Safety set included all participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 19 10
    Participants with SAEs
    0
    0%
    0
    0%
    1
    10%
    Participants with AEs
    13
    100%
    18
    94.7%
    10
    100%
    2. Secondary Outcome
    Title Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
    Description 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).
    Time Frame 12 weeks after last planned dose of study drug (up to Week 60)

    Outcome Measure Data

    Analysis Population Description
    Full analysis set (FAS) included all enrolled participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 19 10
    Number [percentage of participants]
    69.2
    532.3%
    89.5
    471.1%
    40.0
    400%
    3. Secondary Outcome
    Title Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
    Description 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.
    Time Frame 24 weeks after last planned dose of study drug (up to Week 72)

    Outcome Measure Data

    Analysis Population Description
    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).
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 0 0 0
    4. Secondary Outcome
    Title Percentage of Participants With Rapid Virologic Response (RVR)
    Description 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.
    Time Frame Week 4

    Outcome Measure Data

    Analysis Population Description
    FAS included all enrolled participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 19 10
    Number [percentage of participants]
    69.2
    532.3%
    73.7
    387.9%
    70.0
    700%
    5. Secondary Outcome
    Title Percentage of Participants With Extended Rapid Virologic Response (eRVR)
    Description 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.
    Time Frame Week 4 and Week 12

    Outcome Measure Data

    Analysis Population Description
    FAS included all enrolled participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 19 10
    Number [percentage of participants]
    61.5
    473.1%
    73.7
    387.9%
    60.0
    600%
    6. Secondary Outcome
    Title Percentage of Participants With Undetectable HCV RNA at Week 12
    Description 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.
    Time Frame Week 12

    Outcome Measure Data

    Analysis Population Description
    FAS included all enrolled participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 19 10
    Number [percentage of participants]
    69.2
    532.3%
    89.5
    471.1%
    70.0
    700%
    7. Secondary Outcome
    Title Percentage of Participants With On-treatment Virologic Failure
    Description 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.
    Time Frame Baseline up to Week 48

    Outcome Measure Data

    Analysis Population Description
    FAS included all enrolled participants who received at least 1 dose of study drug.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 19 10
    Number [percentage of participants]
    15.4
    118.5%
    5.3
    27.9%
    30.0
    300%
    8. Secondary Outcome
    Title Percentage of Participants With Virologic Relapse
    Description 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.
    Time Frame 12 weeks after planned EOT (up to Week 60)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 9 17 7
    Number [percentage of participants]
    0
    0%
    0
    0%
    0
    0%
    9. Secondary Outcome
    Title Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
    Description 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.
    Time Frame Baseline, On treatment (up to Week 48)

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Overall Participants
    Arm/Group Description 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.
    Measure Participants 41
    Baseline (n = 41)
    2
    15.4%
    On treatment (n = 6)
    6
    46.2%
    10. Secondary Outcome
    Title Maximum Plasma Concentration (Cmax) of Telaprevir
    Description Cmax was measured for telaprevir only.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 13 9
    Mean (Standard Deviation) [nanogram per milliliter (ng/mL)]
    4310
    (1160)
    5050
    (884)
    4060
    (1500)
    11. Secondary Outcome
    Title Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir
    Description Tmax was measured for telaprevir only.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 13 9
    Median (Full Range) [hours (h)]
    4.00
    4.00
    4.00
    12. Secondary Outcome
    Title Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
    Description 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.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    PK population. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 13 13 9
    AUC 0-t last
    39900
    (11300)
    43300
    (9480)
    35300
    (12000)
    AUC 0-12h
    39900
    (11300)
    44100
    (9020)
    35300
    (12000)
    AUC 0-24h
    79900
    (22700)
    88100
    (18000)
    70600
    (24100)
    AUC 0-24h_Adj
    95700
    (29800)
    88600
    (19200)
    76300
    (22800)
    13. Secondary Outcome
    Title Elimination Half-Life (T1/2) of Telaprevir
    Description T1/2 was defined as the time required for the concentration or amount of drug in the body to be reduced by one-half.
    Time Frame 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

    Outcome Measure Data

    Analysis Population Description
    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.
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    Measure Participants 0 0 0

    Adverse Events

    Time Frame Baseline up to Week 52
    Adverse Event Reporting Description
    Arm/Group Title Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Arm/Group Description 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. 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. 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.
    All Cause Mortality
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/13 (0%) 0/19 (0%) 1/10 (10%)
    Infections and infestations
    Infection 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Other (Not Including Serious) Adverse Events
    Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/13 (100%) 18/19 (94.7%) 10/10 (100%)
    Blood and lymphatic system disorders
    Anaemia 4/13 (30.8%) 6 5/19 (26.3%) 5 1/10 (10%) 1
    Neutropenia 4/13 (30.8%) 4 3/19 (15.8%) 5 2/10 (20%) 2
    Leukopenia 1/13 (7.7%) 1 4/19 (21.1%) 5 1/10 (10%) 1
    Lymphadenopathy 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Thrombocytopenia 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Ear and labyrinth disorders
    Ear pain 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Eye disorders
    Eye irritation 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Eye pain 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Eye pruritus 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Mydriasis 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Vision blurred 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Gastrointestinal disorders
    Vomiting 8/13 (61.5%) 13 12/19 (63.2%) 23 6/10 (60%) 12
    Nausea 7/13 (53.8%) 9 5/19 (26.3%) 9 5/10 (50%) 14
    Anal pruritus 4/13 (30.8%) 6 4/19 (21.1%) 5 3/10 (30%) 3
    Abdominal pain 5/13 (38.5%) 5 3/19 (15.8%) 9 1/10 (10%) 1
    Abdominal pain upper 2/13 (15.4%) 2 5/19 (26.3%) 6 0/10 (0%) 0
    Diarrhoea 2/13 (15.4%) 2 3/19 (15.8%) 6 0/10 (0%) 0
    Abdominal distension 2/13 (15.4%) 2 0/19 (0%) 0 0/10 (0%) 0
    Abdominal discomfort 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Anal fissure 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Anorectal discomfort 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Aphthous stomatitis 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Cheilitis 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Constipation 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Diarrhoea haemorrhagic 1/13 (7.7%) 2 0/19 (0%) 0 0/10 (0%) 0
    Dry mouth 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Gingival pain 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Lip ulceration 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Mouth ulceration 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Oral disorder 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Oral pain 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Stomatitis 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Tooth impacted 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Toothache 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    General disorders
    Pyrexia 7/13 (53.8%) 35 11/19 (57.9%) 38 8/10 (80%) 75
    Fatigue 7/13 (53.8%) 7 5/19 (26.3%) 11 3/10 (30%) 7
    Pain 2/13 (15.4%) 6 4/19 (21.1%) 8 5/10 (50%) 23
    Injection site erythema 3/13 (23.1%) 3 2/19 (10.5%) 2 3/10 (30%) 5
    Influenza like illness 1/13 (7.7%) 1 2/19 (10.5%) 3 1/10 (10%) 2
    Chills 2/13 (15.4%) 2 0/19 (0%) 0 1/10 (10%) 2
    Discomfort 1/13 (7.7%) 2 2/19 (10.5%) 10 0/10 (0%) 0
    Injection site pruritus 1/13 (7.7%) 2 0/19 (0%) 0 1/10 (10%) 1
    Injection site rash 1/13 (7.7%) 1 1/19 (5.3%) 1 0/10 (0%) 0
    Malaise 2/13 (15.4%) 4 0/19 (0%) 0 0/10 (0%) 0
    Non-cardiac chest pain 2/13 (15.4%) 3 0/19 (0%) 0 0/10 (0%) 0
    Product taste abnormal 0/13 (0%) 0 2/19 (10.5%) 2 0/10 (0%) 0
    Injection site bruising 0/13 (0%) 0 1/19 (5.3%) 2 0/10 (0%) 0
    Injection site reaction 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Peripheral swelling 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Temperature intolerance 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Vessel puncture site pain 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Immune system disorders
    Seasonal allergy 2/13 (15.4%) 2 0/19 (0%) 0 2/10 (20%) 6
    Infections and infestations
    Oral herpes 1/13 (7.7%) 1 1/19 (5.3%) 1 1/10 (10%) 1
    Bronchitis 1/13 (7.7%) 1 1/19 (5.3%) 1 0/10 (0%) 0
    Pharyngitis streptococcal 0/13 (0%) 0 0/19 (0%) 0 2/10 (20%) 2
    Sinusitis 2/13 (15.4%) 3 0/19 (0%) 0 0/10 (0%) 0
    Urinary tract infection 2/13 (15.4%) 2 0/19 (0%) 0 0/10 (0%) 0
    Vulvovaginal mycotic infection 2/13 (15.4%) 2 0/19 (0%) 0 0/10 (0%) 0
    Conjunctivitis bacterial 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Ear infection 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Gastroenteritis 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Gastroenteritis viral 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Hordeolum 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Nasopharyngitis 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Parvovirus infection 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Pharyngitis 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Pneumonia 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Rash pustular 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Skin infection 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Tinea infection 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Tonsillitis 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Injury, poisoning and procedural complications
    Contusion 2/13 (15.4%) 2 1/19 (5.3%) 1 0/10 (0%) 0
    Excoriation 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Limb injury 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Skin abrasion 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Investigations
    Blood bicarbonate decreased 2/13 (15.4%) 2 0/19 (0%) 0 0/10 (0%) 0
    Blood triglycerides increased 0/13 (0%) 0 2/19 (10.5%) 2 0/10 (0%) 0
    Blood uric acid increased 0/13 (0%) 0 1/19 (5.3%) 1 1/10 (10%) 1
    Weight decreased 1/13 (7.7%) 2 0/19 (0%) 0 1/10 (10%) 1
    Alanine aminotransferase increased 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Blood bilirubin increased 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Blood creatine phosphokinase increased 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Body temperature increased 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Haemoglobin decreased 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Neutrophil count decreased 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Metabolism and nutrition disorders
    Decreased appetite 3/13 (23.1%) 3 5/19 (26.3%) 6 3/10 (30%) 3
    Abnormal loss of weight 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Dehydration 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Hypercholesterolaemia 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Hyperinsulinaemia 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Hypocalcaemia 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 2/13 (15.4%) 2 2/19 (10.5%) 3 0/10 (0%) 0
    Pain in extremity 2/13 (15.4%) 6 2/19 (10.5%) 2 0/10 (0%) 0
    Myalgia 1/13 (7.7%) 1 2/19 (10.5%) 2 0/10 (0%) 0
    Arthralgia 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Neck pain 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Nervous system disorders
    Headache 8/13 (61.5%) 31 16/19 (84.2%) 79 6/10 (60%) 12
    Dizziness 5/13 (38.5%) 7 5/19 (26.3%) 6 0/10 (0%) 0
    Lethargy 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Paraesthesia 0/13 (0%) 0 1/19 (5.3%) 2 0/10 (0%) 0
    Presyncope 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Somnolence 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Psychiatric disorders
    Insomnia 2/13 (15.4%) 2 1/19 (5.3%) 2 1/10 (10%) 1
    Depression 1/13 (7.7%) 1 2/19 (10.5%) 2 0/10 (0%) 0
    Affect lability 0/13 (0%) 0 0/19 (0%) 0 2/10 (20%) 2
    Mood altered 0/13 (0%) 0 2/19 (10.5%) 2 0/10 (0%) 0
    Mood swings 1/13 (7.7%) 1 0/19 (0%) 0 1/10 (10%) 1
    Agitation 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Anxiety 1/13 (7.7%) 2 0/19 (0%) 0 0/10 (0%) 0
    Flat affect 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Restlessness 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Sleep terror 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Reproductive system and breast disorders
    Dysmenorrhoea 1/13 (7.7%) 1 1/19 (5.3%) 3 0/10 (0%) 0
    Amenorrhoea 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Oligomenorrhoea 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Pruritus genital 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 1
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 0/13 (0%) 0 2/19 (10.5%) 3 2/10 (20%) 5
    Cough 0/13 (0%) 0 2/19 (10.5%) 3 1/10 (10%) 1
    Dyspnoea 2/13 (15.4%) 3 1/19 (5.3%) 1 0/10 (0%) 0
    Dyspnoea exertional 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Epistaxis 0/13 (0%) 0 0/19 (0%) 0 1/10 (10%) 2
    Paranasal sinus hypersecretion 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Respiratory distress 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Rhinitis allergic 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Skin and subcutaneous tissue disorders
    Pruritus 3/13 (23.1%) 3 5/19 (26.3%) 10 3/10 (30%) 3
    Rash 4/13 (30.8%) 6 2/19 (10.5%) 2 3/10 (30%) 6
    Alopecia 7/13 (53.8%) 7 1/19 (5.3%) 1 0/10 (0%) 0
    Pruritus generalised 1/13 (7.7%) 1 3/19 (15.8%) 8 0/10 (0%) 0
    Dry skin 0/13 (0%) 0 0/19 (0%) 0 2/10 (20%) 2
    Erythema 1/13 (7.7%) 1 1/19 (5.3%) 4 0/10 (0%) 0
    Skin lesion 1/13 (7.7%) 1 0/19 (0%) 0 1/10 (10%) 1
    Cold sweat 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Eczema 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Rash macular 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Rash papular 0/13 (0%) 0 1/19 (5.3%) 1 0/10 (0%) 0
    Skin irritation 0/13 (0%) 0 1/19 (5.3%) 2 0/10 (0%) 0
    Vascular disorders
    Flushing 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0
    Pallor 1/13 (7.7%) 1 0/19 (0%) 0 0/10 (0%) 0

    Limitations/Caveats

    Study was terminated early because it was determined that telaprevir/Peg-IFN/RBV regimen did not present a meaningful therapeutic treatment over existing interferon-free regimens and was unlikely to be used for participants aged 3 to 17 years.

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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.

    Results Point of Contact

    Name/Title Medical Monitor
    Organization Vertex Pharmaceuticals Incorporated
    Phone 617-341-6777
    Email medicalinfo@vrtx.com
    Responsible Party:
    Vertex Pharmaceuticals Incorporated
    ClinicalTrials.gov Identifier:
    NCT01701063
    Other Study ID Numbers:
    • VX11-950-118
    First Posted:
    Oct 4, 2012
    Last Update Posted:
    Jul 20, 2016
    Last Verified:
    Apr 1, 2016