Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
Study on Chronic Primary Immune Thrombocytopenia (ITP), a condition affecting blood clotting
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.
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
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Age: 18 years or above
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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, regardless of last platelet count (below or above 100 x 10^9 counts/L);
- Patients in remission as per their most recent blood test (platelet count >100 x 10^9 counts/L) and without ITP-specific treatment for less than 1 year
- Adult patient who are 18 years or older at index date
- Patient who has received at least one initial first line therapy (corticosteroids [CS]/ intravenous immunoglobulin [IVIg]/ANTI d) with initial response (platelet count ≥ 50 x 10^9 counts/L) as of index date
Exclusion Criteria:
- Secondary ITP
- Patients in remission as per their most recent blood test (platelet count >100 x 10^9 counts/L) and without ITP-specific treatment for 1 year or more
- 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
This study investigates chronic primary Immune Thrombocytopenia (ITP), a condition where the immune system mistakenly attacks and destroys platelets, which are cells that help blood clot. The purpose of this study is to collect data from adult patients with ITP, focusing on those who have had the condition for more than one year. The study will use patient medical records to confirm diagnoses and gather information.
Participants will have a routine blood test during their clinical visit. This test, a standard part of their care, will also provide additional blood samples to analyze various biomarkers. Data will be collected through chart reviews, clinical assessments, and laboratory results.
- Who can participate: Adults aged 18 or older with chronic primary ITP for over a year living in the USA or UK can participate. They must have received at least one initial treatment and not have secondary ITP or recent infections.
- Study details: Participants will undergo a routine blood test during their clinical visit, which will also be used to collect additional samples for biomarker analysis. Data collection will include reviewing medical charts and assessing clinical outcomes.
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