A Retrospective Study to Evaluate the Use of Thrombopoietin Receptor Agonists (TPO-ra) in Adults With Primary Immune Thrombocytopenia (ITP) in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 275
- 试验地点
- 17
- 主要终点
- Evaluation of the standards of use of TPO-RA in regular clinical practice in Europe
研究概览
简要总结
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.
详细描述
Objectives:
Primary Objective:
To evaluate the standards of use of TPO-RA in regular clinical practice in Europe, with a particular interest on phase of ITP (the phase of the disease will be 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.).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
- •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.
排除标准
- •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
结局指标
主要结局
Evaluation of the standards of use of TPO-RA in regular clinical practice in Europe
时间窗: From the first TPO-RA treatment initiated between 1 January 2014 and 31 December 2018 up to the discontinuation of the last line of treatment with TPO-RA. The maximum follow-up period could be of 10 years.
To evaluate the standards of use of TPO-RA in regular clinical practice in Europe, with reference to phase of ITP (defined according to time when diagnosis of ITP is established in the medical records: newly diagnosed; persistent and chronic), tolerability, safety, posology and remissions, outside controlled clinical trials. The primary end-point is the proportion of patients achieving a complete response (platelet count of ≥100 × 109 /L) or a response (platelet count of ≥30 × 109 /L) after TPO-RA initiation and upon switching. Responses are recorded for any TPO-RA treatment initiated between 1 January 2014 and 31 December 2018 up to the discontinuation of the last line of treatment with TPO-RA.
次要结局
- To analyze the patient characteristics that could affect the choice of TPO-RA for the treatment of ITP and to evaluate the degree of adherence to international guidelines(From the first TPO-RA treatment initiated between 1 January 2014 and 31 December 2018 up to the discontinuation of the last line of treatment with TPO-RA. The maximum follow-up period could be of 10 years.)