Suspended
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
What is being tested
Telaprevir
+ Peginterferon alfa-2b
+ Ribavirin
Drug
Who is being recruted
Blood-Borne Infections+8
+ Communicable Diseases
+ Digestive System Diseases
From 3 to 17 Years
+13 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1 & 2
Interventional
Study Start: January 2013
Summary
Principal SponsorVertex Pharmaceuticals Incorporated
Last updated: July 20, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: January 1, 2013
Actual date on which the first participant was enrolled.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.
Principal SponsorVertex Pharmaceuticals Incorporated
Last updated: July 20, 2016
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
42 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 3 to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Blood-Borne InfectionsCommunicable DiseasesDigestive System DiseasesHepatitisHepatitis, Viral, HumanInfectionsLiver DiseasesRNA Virus InfectionsVirus DiseasesFlaviviridae InfectionsHepatitis C
Criteria
5 inclusion criteria required to participate
Chronic hepatitis C
Hepatitis C virus genotype 1a or b at the Screening Visit
Males or females ages 3 to 17 years of age
Signed informed consent form (ICF), and where appropriate, signed Assent Form
Show More Criteria
8 exclusion criteria prevent from participating
Body weight < 15 kg or > 90 kg
Contraindications to pegylated interferon/ribavirin (Peg-IFN/RBV)
History of non-genotype 1 HCV
History of or prior evidence of a medical condition associated with chronic liver disease other than HCV
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentaltelaprevir + Peginterferon alfa-2b + Ribavirin
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Phoenix, United StatesOpen in Google Maps
San Francisco, United States
Denver, United States
Washington D.C., United States
Suspended23 Study Centers