A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
This trial has no sites in United States.
It has sites in 9 countries. Choose a country to see its sites.
Trial details
- Who runs it
- Takeda
- Trial code
- NCT05576805
- Record updated
- 25 April 2024
- Original description
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.Read full original descriptionShow less
A Multinational, Non-Interventional, Retrospective Study on CMV Infection Outcomes, Treatment Patterns and Healthcare Utilization Study (OTUS) Among Solid Organ Transplant (SOT) Recipients in Europe and Canada (OTUS SOT Extension in the EUCAN Countries: Austria, Belgium, Canada, Greece, Israel, Italy, Netherlands, Poland and Sweden)
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.
No study medicines will be provided to participants in this study.
Inclusion: (Cohort 1) Resistant / Refractory or Intolerant:; Aged greater than or equal to (>=) 18 years at the time of the SOT; Received an SOT after January 1, 2016; Diagnosed with asymptomatic or symptomatic CMV infection any time after the SOT 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 (that is, 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 the Institutional Ethical Committee [IEC]); (Cohort 2) Pre-emptive treatment for CMV viremia:; Aged >=18 years at the time of the SOT; Received an SOT after January 1, 2019; Diagnosed with CMV viremia any time after the SOT date and received pre-emptive anti-CMV agent; Follow-up information is available for at least 12 months from the index date (that is, date when the participant 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 the IEC).
Exclusion: Diagnosed as being positive for human immunodeficiency virus before the SOT; Unable to demonstrate a minimum of 12 months of follow-up from the index date (example, incomplete information on dates showing follow-up time); Participation in a clinical trial related to CMV treatment during the study period .