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

Sanofi

Status: Enrolling

Conditions: Chronic Immune Thrombocytopenia; Adult Immune Thrombocytopenia; Primary Immune Thrombocytopenia

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06665308

OBS18052

U1111-1299-2041 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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