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

Last updated: April 1, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

N/A

Condition

Immune Thrombocytopenia (Itp)

Thrombosis

Dysfunctional Uterine Bleeding

Treatment

No intervention

Clinical Study ID

NCT06665308
OBS18052
U1111-1299-2041
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient diagnosed with chronic (ITP with > 1 year duration) primary ITP living inthe 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 (plateletcount ≥ 50 x 10^9 counts/L) as of index date

Exclusion

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 achronic infection (≤14 days of index date).

  • Patients with vaccination in 28 days before index date

  • Patients treated with rilzabrutinib on or before index date

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
January 13, 2025
Estimated Completion Date:
May 23, 2025

Connect with a study center

  • Imperial College Healthcare NHS Trust,Hammersmith Hospital, Gary Weston Centre_Site Number: 8260001

    London, City Of London W120 HS
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260001

    London, City Of London W120 HS
    United Kingdom

    Active - Recruiting

  • USC Norris Comprehensive Cancer Center- Site Number : 8400002

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • Massachusetts General Hospital- Site Number : 8400001

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003

    Seattle, Washington 98109
    United States

    Active - Recruiting

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