VERTEX 3.0: A European retrospective study in adults with primary ITP
Research type
Research Study
Full title
A retrospective study to evaluate the use of thrombopoietin receptor agonists in adults with primary immune thrombocytopenia in Europe.
IRAS ID
326403
Contact name
Chiara/Claudia Caselin/Guzzoni
Contact email
Sponsor organisation
European Research Consortium on ITP (ERCI) c/o Hematology Project Foundation
Clinicaltrials.gov Identifier
CPMS ID: 56291, Central portfolio management system
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Multicenter, retrospective, European study to evaluate standards of use of thrombopoietin receptor agonists in adult patients with primary immune thrombocytopenia (ITP). Data will be collected by retrospectively reviewing the medical records of patients with ITP who started treatment with thrombopoietin analogues (regardless of phase of the disease) between January 2014 and December 2018.
Each of the 18 sites across UK, Spain, Italy, Norway, France and Switzerland will collect the data from all the patients with ITP who meet the inclusion criteria and agree to participate in the study by signing the informed consent. In order to prevent screening bias, the medical records will be consecutively screened by the investigators, starting with the oldest (regarding start of ITP therapy with TPO-RA), by selecting patients who started therapy with agonists on the date nearest to January 2014. The data will be obtained in a retrospective, non-interventionist manner to meet this study’s objective, by reviewing the patient’s medical records.
The project is coordinated by ERCI founding member Maria Luisa Lozano, from Hospital Universitario Morales Meseguer, Universidad de Murcia, Spain and is conducted in collaboration with the Hematology Project Foundation, Vicenza, Italy.
REC name
London - Fulham Research Ethics Committee
REC reference
23/PR/0788
Date of REC Opinion
25 Aug 2023
REC opinion
Further Information Favourable Opinion