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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

  • 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

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross-Sectional

Recruiting Locations

Massachusetts General Hospital- Site Number : 8400001
Boston, Massachusetts 02114
Contact:
David Kuter, Dr.
617-724-4000
dkuter@partners.org

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.