Use of Thrombopoietin-Receptor Agonists in the management of ITP
Research type
Research Study
Full title
A research study to describe the “real world” use of Thrombopoietin-Receptor Agonists (TRAs) in the management of Immune Thrombocytopenia (ITp) in the UK
IRAS ID
215494
Contact name
Nichola Cooper
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Limited
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Immune Thrombocytopenia (ITP) is a common autoimmune disease which is characterized by low platelet counts, increasing the risk of bleeding. In recent years, Thrombopoeitin-Receptor Agonists (TPO-RAs) have been made available for use in adults suffering with ITP. This study aims to evaluate the responses achieved with TPO-RAs in normal clinical practice in the UK and the adverse effects and side effects associated with TPO-RA treatment.
The study is a multicentre, observational, retrospective research study of patients with ITP involving review of medical records. It will take place in 6 centres in the UK and data from between 130 and 150 patients will be collected.
Retrospective data will be collected from patients’ medical records by trained data collectors. All living patients will be invited to consent to allow a researcher access to their medical records for the purpose of data collection. Since no
consent can be obtained where the patient is deceased and contacting the relatives of deceased patients is likely to cause distress, in these situations members of the direct care team will collect the data from identifiable records and provide anonymised data to researchers for analysis.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
16/WM/0433
Date of REC Opinion
29 Sep 2016
REC opinion
Favourable Opinion