Evaluation of the Use of Thrombopoietin Receptor Agonists in Adults With Primary ITP in Europe
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Trial details
- Who runs it
- European Research Consortium on ITP
- Trial code
- NCT06408324
- Record updated
- 16 May 2024
- Original description
The goal of this multicenter, observational, retrospective is to evaluate the standards of use of thrombopoietin receptor agonists (TPO-RA) in adult patients with primary immune thrombocytopenia (ITP), with a particular interest on phase of ITP (defined according to time when diagnosis of ITP is established in the medical records: newly diagnosed, 0-3 months; persistent, 3-12 months, and chronic, > 12 months), tolerability, safety, posology and remissions, outside controlled clinical trials.Read full original descriptionShow less
A Retrospective Study to Evaluate the Use of Thrombopoietin Receptor Agonists (TPO-ra) in Adults With Primary Immune Thrombocytopenia (ITP) in Europe
The goal of this multicenter, observational, retrospective is to evaluate the standards of use of thrombopoietin receptor agonists (TPO-RA) in adult patients with primary immune thrombocytopenia (ITP), with a particular interest on phase of ITP (defined according to time when diagnosis of ITP is established in the medical records: newly diagnosed, 0-3 months; persistent, 3-12 months, and chronic, > 12 months), tolerability, safety, posology and remissions, outside controlled clinical trials.
Secondary Objectives:
To analyze the patient characteristics that could affect the choice of thrombopoietin receptor agonist for the treatment of ITP, considering specific clinical aspects (such as previous thromboembolic disease, bleeding, platelet count, surgical procedures, etc.).
To evaluate the degree of adherence to international guidelines related to the use of thrombopoietin receptor agonists in regular clinical practice.
Data will be collected through a retrospective chart review of patients with ITP who started TPO-RA treatment between January 2014 and December 2018.
Inclusion: Patients over age 18 when TPO-RA was started; Diagnosis of primary immune thrombocytopenia; Patients who started treatment for ITP with thrombopoietin receptor agonists (romiplostim/eltrombopag) between January 2014 and December 2018; The investigators will review the medical records of patients to include those with longer follow-up in the study, meaning those who started with the agonist on the date closest to January 2014. Patients will be included in chronological order based on date of TPO-RA initiation, and signed informed consent; Signed Informed consent*; An exception will be the case of deceased patients, in which the investigator will sign and date the informed consent document, and will specify the absence of the patient's signature due to death. However, in the event that the codes of the Member State that regulate the processing of personal data of deceased persons do not enable to obtain this information, the specific regulations of each State will be followed.
Exclusion: Patients who had participated in studies with investigational drugs when TPO-RA was started; Patients with a diagnosis of secondary immune thrombocytopenia when TPO-RA was started.