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
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
1 other identifier
interventional
42
6 countries
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2013
Typical duration for phase_1
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 4, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
July 20, 2016
CompletedJuly 20, 2016
April 1, 2016
2.2 years
September 27, 2012
April 18, 2016
June 7, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (12)
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)
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)
Percentage of Participants With Rapid Virologic Response (RVR)
Week 4
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
Week 4 and Week 12
Percentage of Participants With Undetectable HCV RNA at Week 12
Week 12
- +7 more secondary outcomes
Study Arms (1)
Treatment-Naive or Prior Partial/Null Response
EXPERIMENTALtelaprevir + Peginterferon alfa-2b + Ribavirin
Interventions
100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
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
200-mg capsules or 40-mg/mL solution for oral administration
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vertex Pharmaceuticals Incorporatedlead
- Janssen Pharmaceuticalscollaborator
Study Sites (23)
Unknown Facility
Phoenix, Arizona, United States
Unknown Facility
San Francisco, California, United States
Unknown Facility
Denver, Colorado, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Gainesville, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
New York, New York, United States
Unknown Facility
The Bronx, New York, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Brussels, Belgium
Unknown Facility
Wuppertal, Germany
Unknown Facility
Milan, Italy
Unknown Facility
Padua, Italy
Unknown Facility
Pisa, Italy
Unknown Facility
Esplugues de Llobregat, Spain
Unknown Facility
Madrid, Spain
Unknown Facility
Birmingham, United Kingdom
Unknown Facility
Leeds, United Kingdom
Unknown Facility
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and 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.
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 4, 2012
Study Start
January 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
July 20, 2016
Results First Posted
July 20, 2016
Record last verified: 2016-04