A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem Cell Transplant (HSCT) Participants in Europe and Canada
A legfontosabb adatok
- Ki végzi
- Takeda
- Hol
- Ausztria, Belgium, Görögország, Izrael, Kanada, Lengyelország és Szerbia11 helyszín, 7 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 118 fő vett részt
- Kezdés
- 2023. máj. 31.
- Befejezés
- 2024. jan. 31.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A regiszteradat frissítve
- 2024. február 28.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 15 feltétel megnézéseKevesebb
Ki vehet részt
- (Cohort 1) Resistant / Refractory or Intolerant:
- Aged greater than and equal to (>=) 18 years at the time of the HSCT
- Received an HSCT after January 1, 2016
- Diagnosed with CMV infection any time after the HSCT date
- Required >=1 anti-CMV agent to manage CMV infection and were subsequently considered:; resistant to currently available anti-CMV agent; OR; refractory to currently available anti-CMV agent; OR; intolerant to currently available anti-CMV agent
- Follow-up information is available for at least 12 months from the index date (i.e., date when the participant was first considered resistant, refractory or intolerant to anti-CMV agent) or death, whichever occurs first
- Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by Institutional Ethical Committee [IEC]); (Cohort 2) Pre-emptive treatment for CMV viremia:
- Aged >=18 years at the time of the HSCT
- Received an HSCT after January 1, 2019
- Diagnosed with CMV viremia any time after the HSCT date and received pre-emptive anti-CMV agent
- Follow-up information is available for at least 12 months from the index date (i.e., date when the patient was first preemptively treated with an anti-CMV agent) or death, whichever occurs first
- Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by IEC)
Ki nem vehet részt
- Diagnosed as being positive for human immunodeficiency virus before the HSCT
- Unable to demonstrate a minimum of 12 months of follow-up from the index date (e.g., incomplete information on dates showing follow-up time)
- Participation in a clinical trial related to CMV treatment during the study period
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
7 országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe [EU] and Canada [CAN]). Data will be collected retrospectively from medical charts.
A teljes eredeti leírásKevesebb
No study medicines will be provided to participants in this study.
A vizsgálat 2 csoportja
- Cohort 1: Resistant, Refractory, or Intolerant (RRI) to Anti-CMV treatment
Participants who had a HSCT after January 1, 2016, and developed post-transplant CMV infection were subsequently characterized as RRI to currently available anti-CMV treatment for at least 12 months before being enrolled, will be observed in this retrospective study for 24 months.
- Cohort 2: Pre-emptive CMV Treatment
Participants who had a HSCT after January 1, 2019, were preemptively treated for CMV for at least 12 months before being enrolled, will be observed in this retrospective study for 24 months.
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Multinational, Non-Interventional, Retrospective Study on CMV Infection Outcomes, Treatment Patterns and Healthcare Utilization Study (OTUS) Among Hematopoietic Stem Cell Transplant (HSCT) Recipients in Europe and Canada (OTUS HSCT Extension in the EUCAN Countries: Austria, Belgium, Canada, Greece, Israel, Netherlands, Poland and Serbia)
- A regiszteradat frissítve
- 2024. február 28.