Cytomegalovirus (CMV)NCT05576805
A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
An observational study of Cytomegalovirus (CMV), run by Takeda at 15 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus (CMV)
- How many people
- 159 participants
- Where
- 15 sitesin 9 countries
- Study dates
- 19 Jun 2023to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants who had a CMV infection treated with at least one anti-CMV agent and considered resistant, refractory, or intolerant to a currently available agent will be enrolled in Cohort 1 and participants who received pre-emptive therapy for CMV viremia will be enrolled in Cohort 2.
Who may be able to join
- (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
Show all 16Show fewer
- 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).
Who cannot join
- 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 .
Trial locations and contacts
15 sites in 9 countries.
15 sites in 9 countries
Netherlands2 sites
Erasmus UMC
Rotterdam, 3015 GD
UMC Utrech
Utrecht, 3584 CX
About this study
Official title: 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.
Read the detailed description
This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an SOT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an SOT after January 1, 2019. Participants who meet the criteria for both cohorts will be evaluated in each cohort separately (i.e., Cohort 1 and Cohort 2 are not mutually exclusive, and participants will be analyzed in both cohorts using unique index dates with respect to the cohort-specific eligibility criteria). Participant follow-up in the medical record must be available for at least one year from the CMV index date or death, whichever occurs first. The start date of data collection corresponds to the end of participant follow up. For Cohort 1, it is expected that follow-up data will be available for up to 7 years (for those participants with an index date in 2016 and followed through 2022). For Cohort 2, it is expected that follow-up data will be available for up to 4 years (for those participants with an index date in 2019 and followed through 2022).
- Conditions
- Cytomegalovirus (CMV)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from Solid Organ Transplant (SOT) Until Start Date of the Symptomatic or Asymptomatic Index Episode
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Symptomatic episode is an episode wherein there is "Tissue invasive/end organ disease" or "CMV syndrome" at any time, and asymptomatic when there is no such observation.
Measured: From SOT up to start date of the index episode (Up to 7 years 3 months)
Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection. Symptomatic episode is an episode wherein there is "Tissue invasive/end organ disease" or "CMV syndrome" at any time, and asymptomatic when there is no such observation.
Measured: Up to 7 years 3 months
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at the Index Episode and for Recurrent Episodes
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Measured: Up to 7 years 3 months
Time From Start of Index Episode to CMV Viremia Clearance as Defined by Site Investigator
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Measured: From start of index episode to CMV viremia clearance (Up to 7 years 3 months)
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 8 After Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Measured: At Week 8 after index date
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 20 After Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Measured: At Week 20 after index date
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at 1-year After Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate. Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all sites.
Measured: At 1-year after index date
Percentage of Participants With Non-detectable CMV During the Index Episode Prior to and After the Index Date
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) OR pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). The assessment will be based on Kaplan-Meier estimate.
Measured: Up to 7 years 3 months
Percentage of Participants With Evidence of Non-detectable CMV at Week 8 After Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Measured: At Week 8 after index date
Percentage of Participants With Evidence of Non-detectable CMV at Week 20 After Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Measured: At Week 20 after index date
Percentage of Participants With Evidence of Non-detectable CMV at 1-year After Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites.
Measured: At 1-year after index date
Time From Treatment Initiation to CMV Viremia Clearance as Defined by Site Investigator at the Index Episode
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Measured: From Treatment Initiation to CMV Viremia Clearance (Up to 7 years 3 months)
Time From Treatment Initiation Until Evidence of Non-detectable CMV at the Index Episode
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all sites.
Measured: Time from treatment initiation until evidence of non-detectable CMV (Up to 7 years 3 months)
Time from Start of Index Episode to First Symptomatic CMV Diagnosis
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Symptomatic CMV is defined CMV-related tissue invasive disease or CMV syndrome.
Measured: From start of index episode to first symptomatic CMV diagnosis (Up to 7 years 3 months)
Time From Stop Date of the Index Episode to First Recurrent Asymptomatic and Symptomatic CMV Viremia
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection.
Measured: From stop date of the index episode to first recurrent asymptomatic and symptomatic CMV viremia (Up to 7 years 3 months)
Percentage of Participants With Anti-CMV Treatment-related Myelosuppression and Nephrotoxicity
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Percentage of participants with anti-CMV treatment-related myelosuppression each type and nephrotoxicity overall and during the index episode will be reported.
Measured: Up to 7 years 3 months
Percentage of Participants With Organ Rejection From SOT
Organ rejection will include overall and by type (acute, chronic or both for T-cell and anti-body mediated).
Measured: Up to 7 years 3 months
Percentage of Participants With Graft Loss From SOT and the Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Graft loss is defined as lack of a functioning graft attributable to infection, immunological response in the organ recipient, recurrent disease, or recurrent underlying disease as described in the physician notes.
Measured: Up to 7 years 3 months
Percentage of Participants who Died due to any Cause From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date, Percentage of participants who died due to any cause from sot and from the index date will be reported.
Measured: Up to 7 years 3 months
Percentage of Participants who Died due to CMV Infection From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Percentage of participants who died due to CMV infection from SOT and the index date will be reported.
Measured: Up to 7 years 3 months
Number of Genetic Mutations Conferring Anti-CMV Resistance From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Genetic mutation includes UL27, UL54, UL56, UL97, other, unknown mutation. Number of genetic mutations conferring anti-CMV resistance from SOT and at index date will be reported.
Measured: Up to 7 years 3 months
Percentage of Participants With a Genetic Mutation Conferring Anti-CMV Resistance From SOT at the Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Genetic mutation includes UL27, UL54, UL56, UL97, other, unknown mutation. Percentage of participants with genetic mutations conferring anti-CMV resistance from SOT at index date will be reported.
Measured: Up to 7 years 3 months
Secondary outcomes (20)
Percentage of Participants With Anti-CMV Primary or Secondary Prophylaxis and Preemptive Treatment
Primary Prophylaxis is defined as when the start date of the anti-CMV prophylaxis was prior to start date of first CMV episode. Secondary Prophylaxis is defined as when the start date of the anti-CMV prophylaxis was on/ after the end date of the previous CMV episode and before the start date of the subsequent CMV episode, or if the start date of the anti-CMV was after the last CMV episode. Preemptive treatment is defined as anti-CMV treatment was initiated preemptively when the plasma CMV DNA concentration necessitated therapy based on the risk profile of the participant per clinical judgement. Percentage of participants with anti-CMV primary or secondary prophylaxis and preemptive treatment overall, at index episode and for recurrent episodes will be reported.
Measured: Up to 7 years 3 months
Number of Anti-CMV Therapies Used for Primary or Secondary Prophylaxis and Preemptive Treatment
Primary Prophylaxis is defined as when the start date of the anti-CMV prophylaxis was prior to start date of first CMV episode. Secondary Prophylaxis is defined as when the start date of the anti-CMV prophylaxis was on/ after the end date of the previous CMV episode and before the start date of the subsequent CMV episode, or if the start date of the anti-CMV was after the last CMV episode. Preemptive treatment is defined as anti-CMV treatment was initiated preemptively when the plasma CMV DNA concentration necessitated therapy based on the risk profile of the participant per clinical judgement. Number of anti-CMV therapies used for primary or secondary prophylaxis and preemptive treatment will be reported.
Measured: Up to 7 years 3 months
Duration of Anti-CMV Prophylaxis Therapy
Duration of anti-CMV prophylaxis therapy will be reported.
Measured: Up to 7 years 3 months
Percentage of Participants With Mono-therapy and Dual-therapy of Anti-CMV Agents of Interest During CMV Episodes
Monotherapy of anti-CMV agents of interest includes specifically ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir and maribavir, and dual therapy, namely ganciclovir and foscarnet, valganciclovir and foscarnet, cidofovir and valganciclovir, cidofovir and valganciclovir, others which includes acyclovir, valacyclovir, immunoglobulin G (IgG), etc. CMV episode is generally characterized by elevated CMV viremia levels resulting in anti-CMV treatment. Percentage of participants with mono-therapy and dual-therapy of anti-CMV agents of interest during CMV episodes will be reported.
Measured: Up to 7 years 3 months
Number of Individual and Dual-therapy of Anti-CMV Agents Used During CMV Episodes
CMV episode is generally characterized by elevated CMV viremia levels resulting in anti-CMV treatment. Number of individual and dual-therapy of anti-CMV agents used during CMV episodes will be reported.
Measured: Up to 7 years 3 months
Number With Individual and Dual Therapy of Anti-CMV Agents Used by Line of Treatment Overall and During the Index Episodes
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Number of individual and dual therapy of anti-CMV agents used by line of treatment overall and during the index episodes will be reported.
Measured: Up to 7 years 3 months
Duration of Anti-CMV Therapy During CMV Episodes
CMV episode is generally characterized by elevated CMV viremia levels resulting in anti-CMV treatment. Duration of anti-CMV therapy during CMV episodes will be reported.
Measured: Up to 7 years 3 months
Number of Participants With Distribution of Switches of Anti-CMV Agents at the Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Number of participants with distribution of switches of anti-CMV agents at the index date will be reported.
Measured: Up to 7 years 3 months
Percentage of Participants Administered With First, Second, Third and Fourth Line of Anti-CMV Treatments From SOT
Percentage of participants administered with first, second, third and fourth line of anti-CMV treatments from SOT will be reported.
Measured: Up to 7 years 3 months
Time From SOT to Administration of First-line Anti-CMV Agents of Interest and Between First-line Through the Fourth Line of Treatment
Anti-CMV agents of interest includes specifically ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir and maribavir, ganciclovir and foscarnet, valganciclovir and foscarnet, cidofovir and valganciclovir, cidofovir and valganciclovir, others which includes acyclovir, valacyclovir, immunoglobulin G (IgG), etc.
Measured: Up to 7 years 3 months
Number of Participants Based on Reasons for Anti-CMV Dose Changes or Discontinuation for Anti-CMV Agents of Interest
Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection. Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV episode is generally characterized by elevated CMV viremia levels resulting in anti-CMV treatment. Number of participants based on reasons for anti-CMV dose changes or discontinuation for anti-CMV agents of interest overall during CMV episodes, the index episode and for recurrent episodes will be reported.
Measured: Up to 7 years 3 months
Number of Participants With Anti-CMV Agent Administered When Diagnosed With Myelosuppression and Nephrotoxicity
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV episode is generally characterized by elevated CMV viremia levels resulting in anti-CMV treatment.
Measured: Up to 7 years 3 months
Number of Participants Using Immunosuppressant From SOT
Number of participants using immunosuppressant from SOT will be reported.
Measured: Up to 7 years 3 months
Number of Participants With CMV-related Outpatient Clinic Visits From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Number of participants with CMV-related outpatient clinic visits from SOT and index date will be reported.
Measured: From SOT and index date up to 7 years 3 months
Number of Participants Based on Selected Procedures Performed at Outpatient Clinical Visits From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Selected procedures include preemptive monitoring, diagnostic imaging, treatment infusion, toxicities from anti-CMV agents.
Measured: From SOT and index date up to 7 years 3 months
Number of Participants Based on CMV-related Hospitalizations and Emergency Department Visits From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Number of participants based on CMV-related hospitalizations and emergency department visits from SOT and index date will be reported.
Measured: From SOT and index date up to 7 years 3 months
Number of Participants Categorized Based on Reasons for CMV-related Hospitalization
Primary reason for hospitalization will include treatment infusions, CMV progression. Number of participants categorized based on reasons for CMV-related hospitalization will be reported.
Measured: Up to 7 years 3 months
Number of Participants Based on Selected Procedures Performed at Hospitalizations and Emergency Department Visits From SOT and Index Date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Selected procedures will include diagnostic imaging, treatment infusion, toxicities from anti-CMV agents.
Measured: From SOT and index date up to 7 years 3 months
Length of Hospital Stay for CMV-related Hospitalizations and Hospital Acquired CMV Viremia
Length of hospital stay in days for CMV-related hospitalizations and hospital acquired CMV viremia will be reported.
Measured: Up to 7 years 3 months
Duration of Stay in Critical Care and Non-critical Care
Duration in days of stay in critical care and non-critical care will be reported.
Measured: Up to 7 years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start19 Jun 2023
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus (CMV)Studies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576805
- Sponsor's protocol ID
- TAK-620-4003
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2022
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT05576805
- Acronym / sponsor ID
- TAK-620-4003
- Conditions
- Cytomegalovirus (CMV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of two cohorts: Cohort 1 (resistant, refractory or intolerant to anti-CMV agents) includes participants who had an SOT after January 1, 2016. Cohort 2 (pre-emptive treatment for CMV viremia) includes participants who had an SOT after January 1, 2019. Participants who meet the criteria for both cohorts will be evaluated in each cohort separately (i.e., Cohort 1 and Cohort 2 are not mutually exclusive, and participants will be analyzed in both cohorts using unique index dates with respect to the cohort-specific eligibility criteria). Participant follow-up in the medical record must be available for at least one year from the CMV index date or death, whichever occurs first. The start date of data collection corresponds to the end of participant follow up. For Cohort 1, it is expected that follow-up data will be available for up to 7 years (for those participants with an index date in 2016 and followed through 2022). For Cohort 2, it is expected that follow-up data will be available for up to 4 years (for those participants with an index date in 2019 and followed through 2022).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who had a CMV infection treated with at least one anti-CMV agent and considered resistant, refractory, or intolerant to a currently available agent will be enrolled in Cohort 1 and participants who received pre-emptive therapy for CMV viremia will be enrolled in Cohort 2.
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time from Solid Organ Transplant (SOT) Until Start Date of the Symptomatic or Asymptomatic Index Episode
Time frame: From SOT up to start date of the index episode (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Symptomatic episode is an episode wherein there is "Tissue invasive/end organ disease" or "CMV syndrome" at any time, and asymptomatic when there is no such observation.
Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes
Time frame: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection. Symptomatic episode is an episode wherein there is "Tissue invasive/end organ disease" or "CMV syndrome" at any time, and asymptomatic when there is no such observation.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at the Index Episode and for Recurrent Episodes
Time frame: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Time From Start of Index Episode to CMV Viremia Clearance as Defined by Site Investigator
Time frame: From start of index episode to CMV viremia clearance (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 8 After Index Date
Time frame: At Week 8 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at Week 20 After Index Date
Time frame: At Week 20 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With CMV Viremia Clearance as Defined by Site Investigator at 1-year After Index Date
Time frame: At 1-year after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator. The assessment will be based on Kaplan-Meier estimate. Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all sites.
Percentage of Participants With Non-detectable CMV During the Index Episode Prior to and After the Index Date
Time frame: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) OR pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With Evidence of Non-detectable CMV at Week 8 After Index Date
Time frame: At Week 8 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With Evidence of Non-detectable CMV at Week 20 After Index Date
Time frame: At Week 20 after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites. The assessment will be based on Kaplan-Meier estimate.
Percentage of Participants With Evidence of Non-detectable CMV at 1-year After Index Date
Time frame: At 1-year after index date
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date). Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all transplant sites.
Time From Treatment Initiation to CMV Viremia Clearance as Defined by Site Investigator at the Index Episode
Time frame: From Treatment Initiation to CMV Viremia Clearance (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. CMV viremia clearance is defined as when an active CMV viremia can be considered cleared from the participant, as determined by the site investigator.
Time From Treatment Initiation Until Evidence of Non-detectable CMV at the Index Episode
Time frame: Time from treatment initiation until evidence of non-detectable CMV (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Non-detectable CMV is defined as highest minimum detectable level of CMV assays across all sites.
Time from Start of Index Episode to First Symptomatic CMV Diagnosis
Time frame: From start of index episode to first symptomatic CMV diagnosis (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Symptomatic CMV is defined CMV-related tissue invasive disease or CMV syndrome.
Time From Stop Date of the Index Episode to First Recurrent Asymptomatic and Symptomatic CMV Viremia
Time frame: From stop date of the index episode to first recurrent asymptomatic and symptomatic CMV viremia (Up to 7 years 3 months)
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Recurrent episodes is defined as new CMV infection in a participant with previous evidence of CMV infection.
Percentage of Participants With Anti-CMV Treatment-related Myelosuppression and Nephrotoxicity
Time frame: Up to 7 years 3 months
Index episode is first CMV episode in which the participant is considered RRI to anti-CMV treatment or had CMV viremia and received pre-emptive treatment, without becoming RRI during that episode. Percentage of participants with anti-CMV treatment-related myelosuppression each type and nephrotoxicity overall and during the index episode will be reported.
Percentage of Participants With Organ Rejection From SOT
Time frame: Up to 7 years 3 months
Organ rejection will include overall and by type (acute, chronic or both for T-cell and anti-body mediated).
Percentage of Participants With Graft Loss From SOT and the Index Date
Time frame: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Graft loss is defined as lack of a functioning graft attributable to infection, immunological response in the organ recipient, recurrent disease, or recurrent underlying disease as described in the physician notes.
Percentage of Participants who Died due to any Cause From SOT and Index Date
Time frame: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date, Percentage of participants who died due to any cause from sot and from the index date will be reported.
Percentage of Participants who Died due to CMV Infection From SOT and Index Date
Time frame: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Percentage of participants who died due to CMV infection from SOT and the index date will be reported.
Number of Genetic Mutations Conferring Anti-CMV Resistance From SOT and Index Date
Time frame: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Genetic mutation includes UL27, UL54, UL56, UL97, other, unknown mutation. Number of genetic mutations conferring anti-CMV resistance from SOT and at index date will be reported.
Percentage of Participants With a Genetic Mutation Conferring Anti-CMV Resistance From SOT at the Index Date
Time frame: Up to 7 years 3 months
Index date is the date when participant was considered resistant, refractory or intolerant to anti-CMV treatment for the first time after transplant (RRI CMV index date) or pre-emptive treatment for the first time after transplant following CMV viremia (CMV preemptive treatment index date. Genetic mutation includes UL27, UL54, UL56, UL97, other, unknown mutation. Percentage of participants with genetic mutations conferring anti-CMV resistance from SOT at index date will be reported.
20 secondary outcomes
Percentage of Participants With Anti-CMV Primary or Secondary Prophylaxis and Preemptive Treatment
Time frame: Up to 7 years 3 months
Number of Anti-CMV Therapies Used for Primary or Secondary Prophylaxis and Preemptive Treatment
Time frame: Up to 7 years 3 months
Duration of Anti-CMV Prophylaxis Therapy
Time frame: Up to 7 years 3 months
Percentage of Participants With Mono-therapy and Dual-therapy of Anti-CMV Agents of Interest During CMV Episodes
Time frame: Up to 7 years 3 months
Number of Individual and Dual-therapy of Anti-CMV Agents Used During CMV Episodes
Time frame: Up to 7 years 3 months
Number With Individual and Dual Therapy of Anti-CMV Agents Used by Line of Treatment Overall and During the Index Episodes
Time frame: Up to 7 years 3 months
Duration of Anti-CMV Therapy During CMV Episodes
Time frame: Up to 7 years 3 months
Number of Participants With Distribution of Switches of Anti-CMV Agents at the Index Date
Time frame: Up to 7 years 3 months
Percentage of Participants Administered With First, Second, Third and Fourth Line of Anti-CMV Treatments From SOT
Time frame: Up to 7 years 3 months
Time From SOT to Administration of First-line Anti-CMV Agents of Interest and Between First-line Through the Fourth Line of Treatment
Time frame: Up to 7 years 3 months
Number of Participants Based on Reasons for Anti-CMV Dose Changes or Discontinuation for Anti-CMV Agents of Interest
Time frame: Up to 7 years 3 months
Number of Participants With Anti-CMV Agent Administered When Diagnosed With Myelosuppression and Nephrotoxicity
Time frame: Up to 7 years 3 months
Number of Participants Using Immunosuppressant From SOT
Time frame: Up to 7 years 3 months
Number of Participants With CMV-related Outpatient Clinic Visits From SOT and Index Date
Time frame: From SOT and index date up to 7 years 3 months
Number of Participants Based on Selected Procedures Performed at Outpatient Clinical Visits From SOT and Index Date
Time frame: From SOT and index date up to 7 years 3 months
Number of Participants Based on CMV-related Hospitalizations and Emergency Department Visits From SOT and Index Date
Time frame: From SOT and index date up to 7 years 3 months
Number of Participants Categorized Based on Reasons for CMV-related Hospitalization
Time frame: Up to 7 years 3 months
Number of Participants Based on Selected Procedures Performed at Hospitalizations and Emergency Department Visits From SOT and Index Date
Time frame: From SOT and index date up to 7 years 3 months
Length of Hospital Stay for CMV-related Hospitalizations and Hospital Acquired CMV Viremia
Time frame: Up to 7 years 3 months
Duration of Stay in Critical Care and Non-critical Care
Time frame: Up to 7 years 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- To obtain more information on the study, click here/on this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
15 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus (CMV), run by Takeda at 15 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy, Austria, Netherlands, Poland, Sweden and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from Solid Organ Transplant (SOT) Until Start Date of the Symptomatic or Asymptomatic Index Episode (time frame: From SOT up to start date of the index episode (Up to 7 years 3 months)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.