Exjade new formulation study (Eclipse)

• Research type

  Research Study

• Full title

  A randomized, open-label, multicenter, two arm, phase II study to investigate the benefits of an improved deferasirox formulation (film-coated tablet)

• IRAS ID

  152925

• Contact name

  John Porter

• Contact email

  j.porter@ucl.ac.uk

• Eudract number

  2013-004167-32

• Clinicaltrials.gov Identifier

  NCT02125877

• Duration of Study in the UK

  0 years, 10 months, 24 days

• Research summary

  The purpose of the study to find out how a new formulation of deferasirox as a film coated oral tablets (FCT) works as compared to the current marketed Disperable Exjade(deferasirox) tablet (DT) in patients presenting with transfusion-dependent thalassemia. The study will look at the following:
  -Drug saftey
  -If the change in the FCT formulation and its administration with food are associated with better GI tolerability compared to the DT formulation examine the pharmacokinetics of both formulations in patients during chronic treatment
  - assess compliance and patient reported outcomes on palatability and satisfaction (which may have an important impact on patient compliance and adherence)

  Patients will be randomised to either Exjade dispersible tablets (DT) or the new film coated tablet (FCT). Treatment is for 24 weeks.
  

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  14/LO/1802

• Date of REC Opinion

  31 Oct 2014

• REC opinion

  Further Information Favourable Opinion