Идёт набор NCT07587723

A Real-world Study of Treatment Patterns and Outcomes in Primary Immune Thrombocytopenia Patients Treated With Eltrombopag

— Наблюдательное Immune Thrombocytopenia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Immune Thrombocytopenia. Базовые параметры: 18 лет — 100 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швейцария
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Real-world Treatment Patterns and Outcomes of Eltrombopag in Patients With Primary Immune Thrombocytopenia

Обзор

This study aims to describe the treatment patterns and clinical outcomes of treatment with eltrombopag in primary immune thrombocytopenia (ITP) patients treated with prior corticosteroid therapy. This study will use secondary data provided by health care professionals (HCPs) for a sample of primary ITP patients, and primary data from a structured HCP survey. Data will be collected from HCPs working in various clinical centers across the United States (US), United Kingdom (UK), and Germany.

Первичные конечные точки

Number and Percentage of Patients Achieving an Initial Platelet Response Within 12 Weeks of Start of Treatment [Срок оценки: 12 weeks]

Вторичные конечные точки (12)

Number and Percentage of Patients Achieving an Initial Complete Platelet Response Within 12 Weeks of Start of Treatment [Срок оценки: 12 weeks]
Number and Percentage of Patients Achieving a Partial Platelet Response Within 12 Weeks of Start of Treatment [Срок оценки: 12 weeks]
Number and Percentage of Patients With No or Suboptimal Platelet Response Within 12 Weeks of Start of Treatment [Срок оценки: 12 weeks]
Number and Percentage of Patients Achieving Clinically Meaningful Platelet Response Thresholds Within 12 Weeks of Start of Treatment [Срок оценки: 12 weeks]
Time to Platelet Response [Срок оценки: Up to 4 years and 6 months after treatment initiation]
Platelet Counts at Eltrombopag Treatment Initiation [Срок оценки: Day 1]
Platelet Counts at Eltrombopag Treatment Discontinuation [Срок оценки: Up to 4 years and 6 months after treatment initiation]
Number and Percentage of Patients With Bleeding Symptoms During Eltrombopag Treatment [Срок оценки: Up to 4 years and 6 months after treatment initiation]
Duration Between ITP Diagnosis and Eltrombopag Treatment Initiation [Срок оценки: Up to 6 years prior to Day 1 of treatment]
Number and Percentage of Patients With Concomitant Corticosteroid Treatment During Eltrombopag Treatment [Срок оценки: Up to 4 years and 6 months after treatment initiation]
Number and Percentage of Patients With Concomitant Corticosteroid Treatment Withdrawn During Eltrombopag Treatment [Срок оценки: Up to 4 years and 6 months after treatment initiation]
Time to Eltrombopag Treatment Discontinuation [Срок оценки: Up to 4 years and 6 months after treatment initiation]

Критерии участия

Критерии включения

HCP inclusion criteria:

A licensed HCP (e.g., internal medicine specialist, hematologist, hematologist-oncologist or immunologist etc.) involved in the management of adult patients with primary ITP.
Actively involved in treatment decision-making for primary ITP patients at the time of the study.
Have a minimum of 3 years of experience managing patients with primary ITP.
Currently, managing an average of at least 2 adult primary ITP patients per month, including those treated with eltrombopag.
Able and willing to complete a web-based survey (approximately 60 to 70 minutes) and abstract data from 2 eligible patient charts.
Practicing in one of the study countries (US, UK, or Germany).
Have access to a computer or mobile device with internet connectivity to complete the survey.
Not listed as inactive or retired in the panel database.

Patient-level inclusion criteria:

Confirmed diagnosis of primary ITP.
Aged ≥18 years at the time of diagnosis.
Received first-line corticosteroid therapy (with or without intravenous immune globulin \[IVIg\]).
Initiated eltrombopag treatment (with or without corticosteroids) as first non-steroidal ITP treatment between 01 January 2020 and 31 December 2024.
Have at least 6 months of follow-up data available after the index date (unless deceased within that period).

Критерии исключения

HCP exclusion criteria:

Currently employed by a pharmaceutical company or regulatory authority involved in the approval or marketing of treatments for primary ITP.
Unable to provide data for patients who meet the study's inclusion criteria.
Not currently managing patients with primary ITP or are not involved in treatment decisions for these patients.

Patient-level exclusion criteria:

1\. Diagnosis of Evans syndrome, secondary ITP, or non-immune thrombocytopenia.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет