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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorNovartis Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Adult patients diagnosed with primary ITP who were treated with eltrombopag following corticosteroid treatment.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: Eltrombopag Cohort

Trial outcomes

Primary outcomes

1

Number and Percentage of Patients Achieving an Initial Platelet Response Within 12 Weeks of Start of Treatment

Initial platelet response is defined as a platelet count ≥50 × 10\^9/L.

Time frame
12 weeks

Secondary outcomes

1

Number and Percentage of Patients Achieving an Initial Complete Platelet Response Within 12 Weeks of Start of Treatment

Complete platelet response is defined as a platelet count of ≥100 × 10\^9/L.

Time frame
12 weeks
2

Number and Percentage of Patients Achieving a Partial Platelet Response Within 12 Weeks of Start of Treatment

Partial platelet response is defined as a platelet count of ≥30 × 10\^9/L.

Time frame
12 weeks
3

Number and Percentage of Patients With No or Suboptimal Platelet Response Within 12 Weeks of Start of Treatment

No or suboptimal platelet response is defined as a platelet count of \<30 × 10\^9/L.

Time frame
12 weeks
4

Number and Percentage of Patients Achieving Clinically Meaningful Platelet Response Thresholds Within 12 Weeks of Start of Treatment

Clinically meaningful platelet response thresholds as indicated by a platelet count increase from a pretreatment value \<30 × 10\^9/L, and/or documentation of improvement in clinical symptoms such as bleeding.

Time frame
12 weeks

Other outcomes

Sponsors and contacts

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