Vertex:Telaprevir With Peginterferon alfa-2b and Ribavirin
Research type
Research Study
Full 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
IRAS ID
105984
Contact name
Sanjay Bansal
Sponsor organisation
Vertex Pharmaceuticals
Eudract number
2011-004564-30
Clinicaltrials.gov Identifier
Research summary
Hepatitis C is a virus that can infect and damage the liver. In most cases hepatitis C causes no noticeable symptoms until the liver has been significantly damaged. Hepatitis C can be treated with antiviral medicines that are designed to stop the virus from multiplying inside the body and prevent liver damage. Two widely used antiviral medications are called interferon and ribavirin. The different strains of hepatitis C are known as genotypes and some genotypes respond better to treatment than others. The most common genotypes of hepatitis C in England are genotypes 1, 2, 3. With treatment around half of people with genotype 1 will be cured and around 8 out of 10 people with genotypes 2 and 3 will be cured.The Sponsor of this study, Vertex Pharmaceuticals Incorporated, has developed a drug called Telaprevir to treat genotype 1 chronic hepatitis C. Telaprevir, in combination with peginterferon alfa-2b and ribavirin, is an approved treatment in adults with genotype 1 hepatitis C. Telaprevir works to stop the hepatitis C virus from being able to replicate.The Study is being done to learn more about the safety and effects of the combination of Telaprevir, peg-interferon alfa-2b and ribavirin in children with chronic hepatitis C. The sponsor will also look at how Telaprevir/peginterferon alfa-2b and ribavirin may affect the participant's body and how participant's body breaks down and eliminates Telaprevir. This is an Open label study of Telaprevir in Combination with Peginterferon and Ribavirin in treatment naÇîve and treatment experienced children with Genotype 1 Hep C. The study population is children ages between 3 and 17 years old divided into three age groups; 3 to 6, 7 to 12, and 13 to 17 years old. The study is designed in 2 parts: In the first part of the study, children will be treated with Telaprevir in Combination with Peginterferon and Ribavirin. There will be an assessment of safety and pharmacokinetic in 6-10 subjects that are treatment naÇîve in each of the three age groups starting with the oldest group (13-17yo) and for a total of ~ 30 subjects. The second part of the study will begin after the pharmacokinetic and safety has been evaluated in all three age groups and final dosing is confirmed. This is a multicentre study which will take place across Europe and the United States. It is anticipated that approximately 120 patients will be recruited worldwide, 9-12 of those in the UK.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
12/YH/0505
Date of REC Opinion
12 Feb 2013
REC opinion
Further Information Favourable Opinion