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

Novartis

Status: Not yet enrolling

Conditions: Immune Thrombocytopenia

Study type: Observational

Funder types: Industry

Identifiers

NCT07587723

CVAY736I12002

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

HCP inclusion criteria:

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

Patient-level inclusion criteria:

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

Exclusion criteria

HCP exclusion criteria:

1. Currently employed by a pharmaceutical company or regulatory authority involved in the approval or marketing of treatments for primary ITP.
2. Unable to provide data for patients who meet the study's inclusion criteria.
3. 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.

Trial design

150 participants in 1 patient group

Eltrombopag Cohort

Description:

Adult patients diagnosed with primary ITP who initiated eltrombopag treatment between 01 January 2020 and 31 December 2024 following corticosteroid treatment.