Long term follow-up registry for adolescent and paediatric patients
Research type
Research Study
Full title
A Long Term Follow-up Registry for Adolescent and Pediatric Subjects Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
IRAS ID
185573
Contact name
Sanjay Bansal
Contact email
Sponsor organisation
Gilead Sciences, Inc.
Eudract number
2014-004674-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 4 months, 1 days
Research summary
Hepatitis C is an infectious disease, caused by the hepatitis C virus (HCV) that primarily affects the liver. There are 6 main genotypes of HCV. Only 20% of children show symptoms of HCV and the need to for liver transplant is rare, however they may go on to develop liver disease 10 years after onset of infection. Because of the lack of symptoms in children, the European Society for Paediatric Gastroenterology, Hepatology and Nutrition guidelines suggest the primary goal of treating children with HCV should be complete infection eradication. The current standard of care (SOC) for children over the age of 3 is weekly injections of Pegylated Interferon and Ribavirin (RBV) tablets however treatment is over long periods and results in significant poorly tolerates side effects.
Studies of Sofosbuvir (SOF) and of Ledipasvir/Sofosbuvir Fixed Dose Combination (LDV/SOF FDC) in adults have demonstrated high cure rates with excellent tolerability and efficacy. Adult studies have also shown that the use of SOF with RBV or the use of LDV/SOF FDC would provide a shorter, all oral and more tolerable treatment option.
This Registry Study will assess the long term safety and durability in paediatric participants who were treated with SOF + RBV or LDV/SOF FDC +/- RBV. Given the concern of the effect the current SOC treatments may have on growth and development in paediatrics, this study will specifically determine the effect of investigational anti-HCV regimens as determined by assessments of growth and
development. It will also measure the effect of treatment on quality of life and the durability of the treatments by assessing virus relapse (the virus returning) and virus resistance (the virus not responding to treatment).The study is for 5 years and involves the testing of blood samples, completion of Quality of Life Questionnaires and measurement of physical development.
REC name
East of England - Essex Research Ethics Committee
REC reference
15/EE/0371
Date of REC Opinion
20 Nov 2015
REC opinion
Further Information Favourable Opinion