TAPER

• Research type

  Research Study

• Full title

  A phase II, open-label, prospective, single-arm, study to assess ability of eltrombopag to induce sustained remission in subjects with ITP who are refractory or relapsed after first-line steroids (TAPER)

• IRAS ID

  252705

• Contact name

  Nichola Cooper

• Contact email

  n.cooper@imperial.ac.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2018-000452-18

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 0 months, 1 days

• Research summary

  Primary immune thrombocytopenia (ITP) is an autoimmune disorder of adults and children and is defined by a low platelet count of less than 100 x109L. The standard of care for ITP is Corticosteroids. Currently high relapse rates and considerable toxicity associated with use of corticosteroids has highlight a significant unmet medical need in the management of ITP, this is particularly for those patients who relapse after their first treatment.
  New treatments are required to help patients achieve a sustained response and reduce the need for long-term high dose corticosteroid use.

  This is an open labelled study proving Eltrombopag for patients who have relapsed or failed to respond to first line steroid treatment. The study will assess the ability of Eltrombopag to induce a sustained response this is measured by Platelet increase by month 12. In doing so this could then remove the need for further Steroid treatment.
  Study treatment (Eltrombopag) may be given up to a maximum of 12 months. Patients who respond measured by increased Platelet count, will have their dose reduced gradually every 2 weeks until they are discontinued from treatment. Patients will be followed up for response assessment up to 12 months.
  Patients will be required to attend hospital weekly until week 9 then every 2 weeks until 12 months. Patient will be required to provide blood samples, have physical examinations, eye tests and ECG’s. Patients will also be asked to complete questionnaires to monitor quality of life, symptoms, side effects and physical and mental status. Patients will be monitored throughout for safety and tolerability and dose adjustments will be made as appropriate.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  19/EM/0020

• Date of REC Opinion

  28 Mar 2019

• REC opinion

  Further Information Favourable Opinion