PO7614 PK of Boceprevir in CHC Paediatric Patients

• Research type

  Research Study

• Full title

  Assessment of the Pharmacokinetics of Boceprevir in Pediatric Subjects with Chronic Hepatitis C Genotype 1 (Phase 1b)

• IRAS ID

  78128

• Contact name

  Deirdre Kelly

• Sponsor organisation

  Schering-Plough Research Institute.

• Eudract number

  2010-023498-20

• ISRCTN Number

  isrctn

• Research summary

  Although chronic Hepatitis C is a relatively mild disease in children with few symptoms, significant liver damage including severe hepatitis and cirrhosis can occur. Treatment with antivirals, e.g. interferon alpha and ribavirin, can be considered, however there are few treatment options available. In addition, there are limited paediatric data on the use and effectiveness of antivirals in children, making treatment decisions difficult for physicians. Schering Plough is developing a novel treatment for Hepatitis C, boceprevir, which has showed efficacy in Phase II & III trials in adults infected with Hepatitis C Virus Genotype 1 and is generally well tolerated. Treatment responses in children have shown better results than in adults for pegylated-interferon plus ribavirin, suggesting that treatments developed for adults, e.g. Boceprevir, may be suitable for use in children. In order to study the efficacy and safety of boceprevir in children a suitable dose for children needs to be established. This study is designed to determine the dose of boceprevir required for children that will result in a similar exposure seen in adults.As part of Schering Plough's obligation to research and develop Hepatitis C treatments, this study forms part of Paediatric Investigation Plan approved by the EMEA and is a regulatory commitment.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1506

• Date of REC Opinion

  14 Nov 2011

• REC opinion

  Further Information Favourable Opinion