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

Sanofi

Status: Completed

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. 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.

Enrollment: 97 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, , 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.

Exclusion criteria

• 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.