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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
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.