VX-950HPC3006 ( REPLACE) Issue date: 23-Sep-2011

• Research type

  Research Study

• Full title

  Open-Label, Phase 3b Study To Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Hepatitis C Genotype 1 Infected, Stable Liver Transplant Subjects

• IRAS ID

  92482

• Contact name

  David Mutimer

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2011-004724-35

• ISRCTN Number

  na

• Research summary

  In this study telaprevir is being studied for the treatment of patients with a stable liver transplant who also have hepatitis C. The study is looking at the treatment of these patients who will be given telaprevir together with the current Standard of Care therapy (SoC), a combination of two drugs, pegylated interferon and ribavirin. The marketed name for pegylated interferon used in this study is Pegasys©. The marketed name of ribavirin used in this study is Copegus©. Taking telaprevir in addition to pegylated interferon and ribavirin may be more effective in curing people than taking pegylated interferon and ribavirin alone. Liver transplant recipients typically receive therapy with tacrolimus (TAC) or cyclosporin A (CsA) to suppress the immune system. It has been shown that TAC and CsA may become more highly concentrated in the blood (stronger presence) when they are given together with telaprevir. Therefore, during this study, the effects of taking telaprevir along with TAC and CsA will be analyzed. The study will consist of a screening period of approximately 4 weeks, a treatment phase of 48 weeks, and a follow-up period of 24 weeks.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  11/WM/0376

• Date of REC Opinion

  6 Dec 2011

• REC opinion

  Further Information Favourable Opinion