Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
A legfontosabb adatok
- Ki végzi
- Sanofi
- Hol
- Boston, Los Angeles és Seattle (Egyesült Államok)Mind a 3 helyszín megnézéseMég 1 másik országban, 1 helyszínen
- Azonosító
- NCT06665308
- U1111-1299-2041
- Állapot
- Befejeződött
- Résztvevők
- 97 fő vett részt
- Kezdés
- 2025. jan. 13.
- Befejezés
- 2025. nov. 26.
- A vizsgálat típusa
- Megfigyeléses
- A regiszteradat frissítve
- 2026. január 26.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 11 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- 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
- 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 their most recent platelet count >50 x 10\^9 counts/L and without any ITP-specific treatment for more than 1 year
- Secondary ITP
Helyszínek itt: Egyesült Államok
Még 1 másik országban, 1 helyszínen
- Massachusetts General Hospital Site Number : 8400001Boston, Egyesült ÁllamokNo longer taking part
- USC Norris Comprehensive Cancer Center- Site Number : 8400002Los Angeles, Egyesült ÁllamokNo longer taking part
- University of Washington-Fred Hutchinson Cancer Center_Site Number: 8400003Seattle, Egyesült ÁllamokNo longer taking part
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Cognitive Status, Fatigue, and Inflammation in Patients With Immune Thrombocytopenic Purpura (ITP)
- A regiszteradat frissítve
- 2026. január 26.