Examining cognitive status, fatigue, and inflammation in patients with immune thrombocytopenia

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

This study looks at how cognitive function, tiredness, and inflammation are connected in adults who have been living with chronic immune thrombocytopenia for over a year.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sanofi (industry)
• Drugs / interventions: rilzabrutinib
• Locations: 4 sites (Los Angeles, California and 3 other locations)
• Trial ID: NCT06665308 on ClinicalTrials.gov

What this trial studies

This observational study focuses on adult patients diagnosed with chronic primary immune thrombocytopenia (ITP) for over a year. It utilizes a multi-center approach, collecting data from patient medical records and routine clinical visits, where blood samples will be taken to assess various biomarkers. Participants will be identified based on confirmed diagnoses and will undergo standard blood tests as part of their clinical care. The study aims to gather insights into the relationship between cognitive status, fatigue, and inflammation in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with chronic primary ITP who have received at least one first-line therapy.

Not a fit: Patients with secondary ITP or those in remission without ITP-specific treatment for over a year may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of cognitive and fatigue-related issues in patients with immune thrombocytopenia, potentially leading to improved management strategies.

How similar studies have performed: While this study's specific focus is novel, similar observational studies have provided valuable insights into chronic conditions and their impacts on patient quality of life.

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

Where this trial is running

Los Angeles, California and 3 other locations

• USC Norris Comprehensive Cancer Center- Site Number : 8400002 — Los Angeles, California, United States (RECRUITING)
• Massachusetts General Hospital- Site Number : 8400001 — Boston, Massachusetts, United States (RECRUITING)
• University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003 — Seattle, Washington, United States (RECRUITING)
• Investigational Site Number: 8260001 — London, London, City Of, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions: Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia