Menu
Recruiting NCT07587723

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

— Observational Immune Thrombocytopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Immune Thrombocytopenia. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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).

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Switzerland · 1 center
  • Novartis — Basel

Identifiers

NCT: NCT07587723 · CVAY736I12002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗