An observational study in Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia and Adult Immune Thrombocytopenia, sponsored by Sanofi. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Sanofi · Observational
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.
517 studies on the registry are indexed under Purpura, Thrombocytopenic, Idiopathic; 161 are open to participants now.
This study's enrollment of 97 is below the median of 131 across 108 observational studies indexed under Purpura, Thrombocytopenic, Idiopathic.
Browse Purpura, Thrombocytopenic, Idiopathic studies →Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
The source population for this study will be patients treated for primary chronic Immune Thrombocytopenia at one of the four study centers in two countries (3 centers in the USA, 1 center in the UK).
Patient diagnosed with chronic (ITP with > 1 year duration) primary ITP living in the USA or the UK:
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:
Exclusion Criteria:
No intervention will be administered to study participants. Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.
Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients
Impaired cognitive status is defined as a CBB (CogState Brief Battery) z-score of -1 or less on at least one of 2 composite domains (attention/psychomotor composite and memory/learning composite domains). The CBB is a computerized outcome measure of cognitive function in human subjects aged 6 to 99 years and has been previously used in ITP. The CBB test for psychomotor function, attention, visual learning and working memory.
Time frame: Day 1 (Index date)
Age, sex, ethnicity, educational attainment
Time frame: Day 1 (Index date)
Smoking, alcohol, marijuana, cocaine use
Time frame: Day 1 (Index date)
Comorbidities at index categorical
Time frame: Day 1 (Index date)
Current medications
ITP-specific treatments, antiplatelet,anticoagulant, psychiatric and pain medications
Time frame: Day 1 (Index date)
ITP-PAQ
A validated, disease-specifictool to measure health-related quality of life HRQoL in adult ITP patients
Time frame: Day 1 (Index date)
ITP Bleeding Scale (IBLS)
Time frame: Day 1 (Index date)
Medical history
Family history of dementia, family history of cognitive impairment, ITP medication and treatment history, age of ITP diagnosis, duration of ITP, history of clinically relevant or severe bleeding complications, history of thromboembolism complications, history of brain injury or neurological sequalae, history of COVID-19, brain imaging results, platelet counts results
Time frame: Day 1 (Index date)
Laboratory characteristics
Complete Blood Count
Time frame: Day 1 (Index date)
Assessment of key inflammatory biomarkers
Transferrin, Ferritin, Iron, Prothrombin fragment, Fibrinogen, D dimer, Interleukin (IL)-1 beta, IL-6, IL-10, IL-18, TNF alpha, Gamma Interferon, high-sensitivity C-reactive protein (hsCRP), MCP1, NETosis markers (cell-free deoxyribonucleic acid (DNA), neutrophil elastase (NE), myeloperoxidase (MPO)), antinuclear antibodies (ANA), Lupus anticoagulant, Anticardiolipin antibodies (ACA), thrombopoietin level, soluble P-selectin, L-selectin, ICAM-1; whole blood RNA sequencing (transcriptome), C1q, sC5b-9
Time frame: Day 1 (Index date)
FACIT (Functional Assessment of Chronic Illness Therapy) - Fatigue score
The FACIT-Fatigue is a 13-item tool that measures self-reported fatigue and its impact on daily life. Each question is rated by the participant on a Likert-like scale of 0 ('not at all') to 4 ('very much'). A higher FACIT-Fatigue score represents greater quality of life (QoL).
Time frame: Day 1 (Index date)
Plan to share: Yes — Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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