A Study on Cytomegalovirus (CMV) Infection Outcomes Among Hematopoietic Stem Cell Transplant (HSCT) Participants in Europe and Canada
Key facts
- Who runs it
- Takeda
- Where
- Austria, Belgium, Canada, Greece, Israel, Poland, and Serbia11 sites in 7 countriesChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 118 people enrolled
- Started
- 31 May 2023
- Ended
- 31 Jan 2024
- Type of study
- Observational, 2 groups
- Record updated
- 28 February 2024
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- (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)
Who cannot take part
- 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
This trial has no sites in United States.
It has sites in 7 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
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No study medicines will be provided to participants in this study.
The 2 groups in the trial
- 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.
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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)
- Record updated
- 28 February 2024