RECRUITING

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

Conditions

Chronic Immune Thrombocytopenia Primary Immune Thrombocytopenia Adult Immune Thrombocytopenia

Quick Navigation

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. 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:2025-05-23

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, regardless of last platelet count (below or above 100 x 10\^9 counts/L); * Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for less than 1 year * Adult patient who are 18 years or older at index date * Patient who has received at least one initial first line therapy (corticosteroids \[CS\]/ intravenous immunoglobulin \[IVIg\]/ANTI d) with initial response (platelet count ≥ 50 x 10\^9 counts/L) as of index date	* Secondary ITP * Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for 1 year or more * 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

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, regardless of last platelet count (below or above 100 x 10\^9 counts/L);
* Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for less than 1 year
* Adult patient who are 18 years or older at index date
* Patient who has received at least one initial first line therapy (corticosteroids \[CS\]/ intravenous immunoglobulin \[IVIg\]/ANTI d) with initial response (platelet count ≥ 50 x 10\^9 counts/L) as of index date

* Secondary ITP
* Patients in remission as per their most recent blood test (platelet count \>100 x 10\^9 counts/L) and without ITP-specific treatment for 1 year or more
* 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

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)

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 Date2025-05-23

Study Record Updates

Study Start Date2025-01-13

Study Completion Date2025-05-23

Terms related to this study

Additional Relevant MeSH Terms

Chronic Immune Thrombocytopenia
Primary Immune Thrombocytopenia
Adult Immune Thrombocytopenia