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

Launched by SANOFI · Oct 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how cognitive status, fatigue, and inflammation affect adults with chronic Immune Thrombocytopenia (ITP), a condition where the body doesn't produce enough platelets, which are important for blood clotting. The study will involve adults who have had ITP for more than a year and are currently receiving treatment. Participants will be identified through their medical records and will need to give their consent to take part.

If eligible, once you agree to join, your routine visit to the clinic will also serve as the study visit. This means you'll have a blood test, which is part of your normal care, and additional samples will be taken to look at different biomarkers, which are substances in the blood that can give insights into your health. To qualify, you need to be at least 18 years old, have a confirmed diagnosis of chronic primary ITP, and have undergone at least one type of initial treatment for the condition. Notably, those with secondary ITP or certain recent infections may not be able to participate. This study hopes to improve understanding of how ITP affects overall health and well-being.

Gender

ALL

Eligibility criteria

• 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