Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)

Study of Cognitive Status, Fatigue, and Inflammation in Patients with Immune Thrombocytopenia

Recruiting
18 years or above
All
Phase N/A
110 participants needed
3 Locations

Study Overview

This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results. The study will include adult patients with chronic (> 1 year duration) primary Immune Thrombocytopenia (ITP) only. Patients will be identified based on a laboratory confirmed diagnosis of ITP in the medical records, where there is also a physician-confirmed diagnosis of primary ITP. If patients consent to take part in the study, a routine clinical visit will also serve as the study visit. Patients who do not have a routine visit scheduled during the study period but who would otherwise be eligible may be contacted by the site. In such cases, clinicians may use their discretion to schedule a visit specifically for study purposes.

All study participants will have a routine blood test as part of their standard clinical care at the study visit, and this same procedure will be used to collect supplementary blood samples to assess a variety of biomarkers.

Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Patient diagnosed with chronic (ITP with > 1 year duration) primary ITP living in the USA or the UK:
    • On ITP pharmacologic treatment, , including on-demand treatment strategy, regardless of last platelet count (below or above 100 x 10^9 counts/L);
    • Patients with their most recent platelet count >50 x 109 counts/L) and without any ITP-specific treatment for 1 year or less.
  • Adult patient who are 18 years or older at index date
  • Patient who has received at least one initial first line ITP therapy (CS/ IVIg/ANTI d) with initial response as of index date and indicated by one of the following:
    • Platelet count ≥ 50 x 10^9 counts /L; OR
    • Platelet count ≥ 30 x 10^9 counts /L with at least a two-fold increase from baseline within 1 month since start of treatment, as per ASH 2019 guidelines; OR
    • A medical record of initial response as determined by clinical judgement, considering documented platelet count along with overall patient condition and relevant medical factors.
  • Patients whose medical history related to the study objectives are available from

    the site covering 12 months prior to index date.

  • Patient provided informed consent to participate in the study.

Exclusion Criteria:

  • Secondary ITP.
  • Patients with their most recent platelet count >50 x 10^9 counts/L and without any ITP-specific treatment for more than 1 year.
  • Patients with recent or active infection recorded 14 days or less before index date; patients with uncontrolled chronic infections or who were recently diagnosed with a chronic infection (≤14 days of index date).
  • Patients with vaccination in 28 days before index date.
  • Patients treated with rilzabrutinib on or before index date.
  • Patients who participated in an interventional clinical trial for any investigational drug in the 180 days prior to index date.

This study investigates the cognitive status, fatigue, and inflammation in patients with chronic primary Immune Thrombocytopenia (ITP). This study will focus on adult patients who have been diagnosed with ITP for more than one year.

Participants will undergo a routine blood test as part of their standard clinical care during a study visit. Additional blood samples will be collected to assess various biomarkers. Data will also be gathered from medical records and clinical assessments to better understand the effects of ITP on cognitive function and fatigue.

  • Who can participate: Adults 18 years or older with chronic primary ITP diagnosed for more than one year can participate. Participants must be living in the USA or the UK and have received at least one initial first-line therapy with a positive response. Exclusions include secondary ITP, recent infections, recent vaccinations, or treatment with rilzabrutinib.
  • Study details: Participants will attend a clinical visit where routine blood tests will be conducted. Additional blood samples will be collected for research purposes. Data will be gathered from medical records and clinical assessments.
Updated on 07 Nov 2025. Study ID: NCT06665308

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