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

NCT ID: NCT06665308

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 97 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-13
• Study Completion Date: 2025-11-26

Brief 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.

Conditions

Chronic Immune Thrombocytopenia; Primary Immune Thrombocytopenia; Adult Immune Thrombocytopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Interventions

No intervention

No intervention will be administered to study participants. Data will be collected using a combination of chart review, clinical outcome assessment administration, and laboratory results through blood tests.

Intervention Type: OTHER

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, , 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

USC Norris Comprehensive Cancer Center- Site Number : 8400002

Los Angeles, California, United States

Massachusetts General Hospital- Site Number : 8400001

Boston, Massachusetts, United States

University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003

Seattle, Washington, United States

Investigational Site Number: 8260001

London, London, City of, United Kingdom

Countries

United States; United Kingdom

Other Identifiers

U1111-1299-2041

Identifier Type: OTHER

Identifier Source: secondary_id

OBS18052

Identifier Type: -

Identifier Source: org_study_id