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

NCT06665308 | Completed

• 2 other identifiers: OBS18052U1111-1299-2041
• Study Type: observational
• Target: 97
• Locations: 2 countries
• Sites: 4

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

Adult Immune Thrombocytopenia; Primary Immune Thrombocytopenia; Chronic Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Prevalence of impaired cognitive status among adult Immune Thrombocytopenia patients

  Impaired cognitive status is defined as a CBB (CogState Brief Battery) z-score of -1 or less on at least one of 2 composite domains (attention/psychomotor composite and memory/learning composite domains). The CBB is a computerized outcome measure of cognitive function in human subjects aged 6 to 99 years and has been previously used in ITP. The CBB test for psychomotor function, attention, visual learning and working memory.

  Day 1 (Index date)

Secondary Outcomes (10)

• Age, sex, ethnicity, educational attainment

  Day 1 (Index date)

• Smoking, alcohol, marijuana, cocaine use

  Day 1 (Index date)

• Comorbidities at index categorical

  Day 1 (Index date)

• Current medications

  Day 1 (Index date)

• ITP-PAQ

  Day 1 (Index date)

Interventions

No intervention OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The source population for this study will be patients treated for primary chronic Immune Thrombocytopenia at one of the four study centers in two countries (3 centers in the USA, 1 center in the UK).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

USC Norris Comprehensive Cancer Center- Site Number : 8400002

Los Angeles, California, 90033, United States

Location

Massachusetts General Hospital- Site Number : 8400001

Boston, Massachusetts, 02114, United States

Location

University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003

Seattle, Washington, 98109, United States

Location

Investigational Site Number: 8260001

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

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 30, 2024
• Study Start: January 13, 2025
• Primary Completion: November 26, 2025
• Study Completion: November 26, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); US (3)