Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
Key facts
- Who runs it
- Sanofi
- Where
- Boston, Los Angeles, and Seattle, United StatesSee the 3 sitesAlso in 1 other country, 1 site
- Trial code
- NCT06665308
- U1111-1299-2041
- Status
- Completed
- People taking part
- 97 people enrolled
- Started
- 13 Jan 2025
- Ended
- 26 Nov 2025
- Type of study
- Observational
- Record updated
- 26 January 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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 their most recent platelet count >50 x 10\^9 counts/L and without any ITP-specific treatment for more than 1 year
- Secondary ITP
Where in United States
Also in 1 other country, 1 site
- Massachusetts General Hospital Site Number : 8400001Boston, United StatesNo longer taking part
- USC Norris Comprehensive Cancer Center- Site Number : 8400002Los Angeles, United StatesNo longer taking part
- University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003Seattle, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
- Record updated
- 26 January 2026