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

Last updated: January 23, 2026
Sponsor: Sanofi
Overall Status: Completed

Phase

N/A

Condition

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Thrombosis

Immune Thrombocytopenia (Itp)

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. 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.

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, , 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 withoutany 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/ANTId) 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 frombaseline 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 andrelevant medical factors.

  • Patients whose medical history related to the study objectives are available fromthe site covering 12 months prior to index date.

  • Patient provided informed consent to participate in the study.

Exclusion

Exclusion Criteria:

  • Secondary ITP.

  • Patients with their most recent platelet count >50 x 10^9 counts/L and without anyITP-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 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.

  • Patients who participated in an interventional clinical trial for anyinvestigational drug in the 180 days prior to index date.

Study Design

Total Participants: 97
Treatment Group(s): 1
Primary Treatment: No intervention
Phase:
Study Start date:
January 13, 2025
Estimated Completion Date:
November 26, 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, London, City Of W120 HS
    United Kingdom

    Site Not Available

  • Investigational Site Number: 8260001

    London 2643743, London, City of W12 0HS
    United Kingdom

    Site Not Available

  • USC Norris Comprehensive Cancer Center- Site Number : 8400002

    Los Angeles, California 90033
    United States

    Site Not Available

  • USC Norris Comprehensive Cancer Center- Site Number : 8400002

    Los Angeles 5368361, California 5332921 90033
    United States

    Site Not Available

  • University Of Southern California- Site Number : 8400002

    Los Angeles 5368361, California 5332921 90033
    United States

    Active - Recruiting

  • Massachusetts General Hospital- Site Number : 8400001

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Massachusetts General Hospital- Site Number : 8400001

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

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

    Seattle, Washington 98109
    United States

    Site Not Available

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

    Seattle 5809844, Washington 5815135 98109
    United States

    Site Not Available

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