Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
Completed
Conditions studied: Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
In brief
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.
Key facts
- Study ID
- NCT06665308
- Run by
- Sanofi
- People needed
- 97
- Starts
- 2025-01-13
- Expected to finish
- 2025-11-26
- Last updated by the study team
- 2026-01-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- USC Norris Comprehensive Cancer Center- Site Number : 8400002 — Los Angeles, California, United States
- Massachusetts General Hospital- Site Number : 8400001 — Boston, Massachusetts, United States
- University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003 — Seattle, Washington, United States
- Investigational Site Number: 8260001 — London, London, City of, United Kingdom
Full record on ClinicalTrials.gov
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