Clinical trial NCT01701063: 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
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
Collaborators: name: Janssen Pharmaceuticals
First posted: 2012-10-04
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Percentage of Participants With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
timeFrame: 12 weeks after last planned dose of study drug (up to Week 60)
measure: Percentage of Participants With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
timeFrame: 24 weeks after last planned dose of study drug (up to Week 72)
measure: Percentage of Participants With Rapid Virologic Response (RVR)
timeFrame: Week 4
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: Week 4 and Week 12
measure: Percentage of Participants With Undetectable HCV RNA at Week 12
timeFrame: Week 12
measure: Percentage of Participants With On-treatment Virologic Failure
timeFrame: Baseline up to Week 48
measure: Percentage of Participants With Virologic Relapse
timeFrame: 12 weeks after planned EOT (up to Week 60)
measure: Number of Participants With Telaprevir Resistant HCV Variant at Non-Structural Viral Protein 3-4A (NS3-4A) Region
timeFrame: Baseline, On treatment (up to Week 48)
measure: Maximum Plasma Concentration (Cmax) of Telaprevir
timeFrame: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Telaprevir
timeFrame: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) of Telaprevir
timeFrame: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
measure: Elimination Half-Life (T1/2) of Telaprevir
timeFrame: Cohort 1: Pre-dose and 0.5, 1.0, 2.0, 3.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 2: Pre-dose and 0.5, 2.0, 4.0, 5.0, 6.0, and 8.0 hours post-dose on Day 7, Cohort 3: Pre-dose and 1.5, 4.0, and 8.0 hours post-dose on Day 7
Other outcomes:
Locations:
city: Phoenix
country: United States
state: Arizona
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Gainesville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Indianapolis
country: United States
state: Indiana
city: Baltimore
country: United States
state: Maryland
city: Bronx
country: United States
state: New York
city: New York
country: United States
state: New York
city: Philadelphia
country: United States
state: Pennsylvania
city: Houston
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Brussel
country: Belgium
city: Bruxelles
country: Belgium
city: Wuppertal
country: Germany
city: Milano
country: Italy
city: Padova
country: Italy
city: Pisa
country: Italy
city: Esplugues de Llobregat
country: Spain
city: Madrid
country: Spain
city: Birmingham
country: United Kingdom
city: Leeds
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: