MedDataX Logo

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

NCT ID: NCT06665308

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-13

Study Completion Date

2025-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Immune Thrombocytopenia Primary Immune Thrombocytopenia Adult Immune Thrombocytopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

USC Norris Comprehensive Cancer Center- Site Number : 8400002

Los Angeles, California, United States

Site Status RECRUITING

Massachusetts General Hospital- Site Number : 8400001

Boston, Massachusetts, United States

Site Status RECRUITING

University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003

Seattle, Washington, United States

Site Status RECRUITING

Investigational Site Number: 8260001

London, London, City of, United Kingdom

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Trial Transparency email recommended (Toll free for US & Canada)

Role: CONTACT

Phone: 800-633-1610

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Christine Duran

Role: primary

David Kuter, Dr.

Role: primary

Sandhya Ramanathan Panch, Dr

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1299-2041

Identifier Type: OTHER

Identifier Source: secondary_id

OBS18052

Identifier Type: -

Identifier Source: org_study_id