A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
NCT ID: NCT05576805
Last Updated: 2024-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
159 participants
OBSERVATIONAL
2023-06-19
2024-03-31
Brief Summary
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No study medicines will be provided to participants in this study.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cohort 1: Resistant, Refractory, or Intolerant (RRI) to Anti-CMV Treatment
Participants who had an SOT after January 1, 2016 and must have developed post-transplant CMV infection and were subsequently characterized as RRI to currently available anti-CMV treatment at least 12 months before enrollment in the study will be observed in this retrospective study for 24 months.
No interventions assigned to this group
Cohort 2: Pre-emptive CMV Treatment
Participants who had an SOT after January 1, 2019, and who were preemptively treated for CMV at least 12 months before enrollment in the study will be observed in this retrospective study for 24 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
1. Aged greater than or equal to (\>=) 18 years at the time of the SOT.
2. Received an SOT after January 1, 2016.
3. Diagnosed with asymptomatic or symptomatic CMV infection any time after the SOT date.
4. Required \>=1 anti-CMV agent to manage CMV infection and were subsequently considered:
1. resistant to currently available anti-CMV agent; OR
2. refractory to currently available anti-CMV agent; OR
3. intolerant to currently available anti-CMV agent.
5. 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.
6. 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:
1. Aged \>=18 years at the time of the SOT.
2. Received an SOT after January 1, 2019.
3. Diagnosed with CMV viremia any time after the SOT date and received pre-emptive anti-CMV agent.
4. 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.
5. Provided written informed consent prior to the initiation of any study procedures (unless waiver was granted by the IEC).
Exclusion Criteria
2. Unable to demonstrate a minimum of 12 months of follow-up from the index date (example, incomplete information on dates showing follow-up time).
3. Participation in a clinical trial related to CMV treatment during the study period .
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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MU Graz
Graz, , Austria
MU Innsbruck
Innsbruck, , Austria
UZ Leuven
Leuven, , Belgium
Vancouver GH (VCH)
Vancouver, British Columbia, Canada
Aristotle USM
Thessaloniki, , Greece
Rabin Medical Center
Petah Tikva, , Israel
U Parma
Parma, , Italy
FP Vergata
Roma, , Italy
U Insubria
Varese, , Italy
Erasmus UMC
Rotterdam, , Netherlands
UMC Utrech
Utrecht, , Netherlands
UCC Gdansk
Gdansk, , Poland
MU Warsaw
Warsaw, , Poland
Karolinska UH
Solna, , Sweden
Uppsala UH
Uppsala, , Sweden
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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TAK-620-4003
Identifier Type: -
Identifier Source: org_study_id
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