TAK-620-4003

Recruiting

A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada

Clinicaltrials.gov

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.

IT

SE

PL

6+

Observational clinical trial.

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What medical conditions are being studied?

Cytomegalovirus (CMV)

How many participants are being enrolled?

240

Are placebos part of the clinical trial?

No

When is the clinical trial being conducted?

Jun 2023 - Mar 2024

How long is participation in the clinical trial?

Not applicable for this data collection study.

Sex

All

Age

18+ years

Healthy volunteers?

No

Must be women and men 18 years or older at the time of Solid Organ Transplant (SOT).

Cohort 1:

Must have received an SOT after January 1, 2016.

Must be diagnosed with asymptomatic or symptomatic Cytomegalovirus (CMV) infection.

Must have required 1 or more anti-CMV agent and considered resistant, refractory or intolerant to currently available anti-CMV agent.

Cohort 2:

Must have received an SOT after January 1, 2019.

Must be diagnosed with CMV viremia and received pre-emptive anti-CMV agent.

Primary outcome measures

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)]

Percentage of Participants who are Asymptomatic and Symptomatic at the Index and Recurrent Episodes [Time Frame: 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 [Time Frame: Up to 7 years 3 months]

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)]

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]

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]

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]

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]

Percentage of Participants With Evidence of Non-detectable CMV at Week 8 After Index Date [Time Frame: At Week 8 after index date]

Percentage of Participants With Evidence of Non-detectable CMV at Week 20 After Index Date [Time Frame: At Week 20 after index date]

Percentage of Participants With Evidence of Non-detectable CMV at 1-year After Index Date [Time Frame: At 1-year after index date]

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)]

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)]

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)]

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)]

Percentage of Participants With Anti-CMV Treatment-related Myelosuppression and Nephrotoxicity [Time Frame: Up to 7 years 3 months]

Percentage of Participants With Organ Rejection From SOT [Time Frame: Up to 7 years 3 months]

Percentage of Participants With Graft Loss From SOT and the Index Date [Time Frame: Up to 7 years 3 months]

Percentage of Participants who Died due to any Cause From SOT and Index Date [Time Frame: Up to 7 years 3 months]

Percentage of Participants who Died due to CMV Infection From SOT and Index Date [Time Frame: Up to 7 years 3 months]

Number of Genetic Mutations Conferring Anti-CMV Resistance From SOT and Index Date [Time Frame: Up to 7 years 3 months]

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]

Secondary outcome measures

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]

Recruiting

A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada

About this clinical trial

At a glance

What medical conditions are being studied?