CRAD001H2304E1 everolimus in liver transplant extension study

• Research type

  Research Study

• Full title

  Extension study to the multicenter, open-label, randomized, controlled study CRAD001H2304 to evaluate the long-term efficacy and safety of concentration controlled everolimus in liver transplant recipients

• IRAS ID

  61713

• Contact name

  Marius Scholtz

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2009 017311 15

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This study is an up to 24-month extension to the multicentre, open-label, randomised, and controlled study CRAD001H2304 and will include patients who completed the core study CRAD001H2304, i.e., male and female primary liver transplantation patients, about 20 to 72 years of age, who have received a liver from a deceased donor and are 36 months post-transplant. As part of this extension study, patients will be receiving everolimus (RAD001) for up to Month 48 post-transplantation.The main aim of this extension study is to evaluate long-term safety and efficacy of the study drug, everolimus (RAD001), in this group of patients following a liver transplant. The analysis will focus on evaluation of renal function, treatment related effects (progression of Hep C related fibrosis), maintenance of efficacy (graft loss/death/BPAR), other clinically significant findings (adverse events, serious adverse events, infections, and major adverse cardiac events) and laboratory values.All patients will be studied for 12 months with some patients (those receiving everolimus) being studied for up to 24 months. The end of study will be reached, when the last patient who enters the extension study has been in the study for 12 months.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  10/H0606/64

• Date of REC Opinion

  3 Dec 2010

• REC opinion

  Further Information Favourable Opinion