RECRUITING

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

Conditions

Chronic Immune Thrombocytopenia Primary Immune Thrombocytopenia Adult Immune Thrombocytopenia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-13

Study Completion:2025-12-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06665308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

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

CONTACT

800-633-1610

contact-us@sanofi.com

Study Locations (Sites)

USC Norris Comprehensive Cancer Center- Site Number : 8400002

Los Angeles, California, 90033

United States

Massachusetts General Hospital- Site Number : 8400001

Boston, Massachusetts, 02114

United States

University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003

Seattle, Washington, 98109

United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-13

Study Completion Date2025-12-12

Study Record Updates

Study Start Date2025-01-13

Study Completion Date2025-12-12

Terms related to this study

Additional Relevant MeSH Terms

Chronic Immune Thrombocytopenia
Primary Immune Thrombocytopenia
Adult Immune Thrombocytopenia