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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
USC Norris Comprehensive Cancer Center- Site Number : 8400002
RECRUITING
Los Angeles
Massachusetts
Massachusetts General Hospital- Site Number : 8400001
RECRUITING
Boston
Washington
University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003
RECRUITING
Seattle
Other Locations
United Kingdom
Investigational Site Number: 8260001
RECRUITING
London
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2025-12-12
Participants
Target number of participants: 110
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov