Cytomegalovirus (CMV)NCT06615921
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection
An observational study of Cytomegalovirus (CMV), run by Takeda at 45 sites in 10 countries.
Trial summary
The main aim of this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus (CMV)
- How many people
- 265 participants
- Where
- 45 sitesin 10 countries
- Study dates
- 14 Oct 2024to 4 Jul 2025
- 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 have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.
Who may be able to join
- Aged greater than or equal to (>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation.
- Received an HSCT/SOT.
- Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
- Initiated maribavir at least 4 months before the chart abstraction date (or at time of Central Ethics Committee [CEC]/Local Ethics Committee [LEC] submission as per local regulation).
- Participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation).
Who cannot join
- Participants who do not provide informed consent, where consent is required per country regulations.
- Participants who participated to Clinical Trials investigating maribavir.
Trial locations and contacts
45 sites in 10 countries.
45 sites in 10 countries
Germany11 sites
Uniklinik RWTH Aachen
Aachen, 52074
Charite, Dept of Nephrology
Berlin, 10117
Clinic for Infectiology - Essen
Essen, 45147
University Hospital Greifswald
Greifswald, 17475
Clinic for stem cell transplantation - Hamburg (UKE)
Hamburg, 20246
Hannover Medical School - Resp Medicine
Hanover, 30625
Uniklinik Leipzig
Leipzig, 04103
Medicine Clinic of Johannes Gutenberg - Mainz university
Mainz, 55131
Ludwig-Maximilians University (LMU) Hospital
Munich, 80336
University of Ulm
Ulm, 89081
Universitaetsklinikum Wuerzburg
Würzburg, 97080
France10 sites
Groupe Hospitalier Pellegrin - CHU BORDEAUX
Bordeaux, 33000
Department of Nephrology, University Hospital of Dijon
Dijon, 21000
Hopital Claude Huriez CHRU Lille
Lille, 59000
CHU Montpellier
Montpellier, 34295
CHU De Nice Hopital Pasteur 2
Nice, 06000
Hopital Saint-Louis AP-HP Pitor
Paris, 75010
APHP, Sorbonne University, Pitie Salpetriere Hospital
Paris, 75013
Necker-Enfants Malades Hospital
Paris, 75015
Hopitaux Universitaires de Strasbourg
Strasbourg, 67000
Toulouse University Hospital - Hopital de Rangueil
Toulouse, 31400
United Kingdom9 sites
University Hospitals Birmingham
Birmingham, B15 2GW
Royal Papworth Hospital (Cambridge)
Cambridge, CB2 0AY
University College Hospital London
London, NW1 2BU
Kings College Hospital (London)
London, SE5 9RS
Royal Marsden Hospital (London)
London, SW3 6JJ
Manchester Royal Infirmary
Manchester, M13 9WL
Freeman Hospital Newcastle upon Tyne
Newcastle, NE7 7DN
Nottingham University Hospital NHS trust (Queens Medical Centre)
Nottingham, NG5 1PB
University Hospital Southampton NHS FT
Southampton, SO16 6YD
Spain7 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital de Cruces
Bilbao, 48903
Hospital Virgen de las Nieves
Granada, 18014
Hospital Dr. Negrin
Las Palmas, 35010
Hospital 12 de Octubre
Madrid, 28041
Hospital Puerta del Hierro
Madrid, 28222
Hospital Universitario Marques de Valdecilla
Santander, 39008
Netherlands2 sites
Erasmus MC Cancer Institute
Rotterdam, 3015
UMC Utrecht (Hematology)
Utrecht, 3584
Serbia2 sites
University of Belgrade
Belgrade, 11000
Clinical Center of Vojvodina
Novi Sad, 21000
Austria1 site
Medical University of Vienna Dept. of Nephrology and Dialysis
Vienna, 1090
About this study
Official title: A Multi-country, Multi-center, Retrospective Chart Review to Describe the Use of Maribavir and Its Effectiveness in Patients With Post-Transplant Cytomegalovirus Infection/Disease
The main aim of this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant. Other aims are to learn more about how maribavir is used in normal clinical routine, study the profiles of adults treated with maribavir, and what other treatments have been given, and describe healthcare resources used for CMV management.
Only data already available in the medical records of the participants will be reviewed and collected during this study.
Read the detailed description
This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.
- Conditions
- Cytomegalovirus (CMV)
- Being tested
- No Intervention
- Keywords
- Drug Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
This is a non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Participants With CMV Infection Refractory | Participants who had a CMV infection/disease that is refractory to treatment (with or without resistance). Data will be retrospectively collected from date of solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Participants will be considered as refractory if they show no change or increased viremia after at least 2 weeks of appropriately dosed antiviral therapy. Receives: Other: No Intervention | |
| Participants With CMV Infection Intolerant | Participants with CMV infection intolerant to anti-CMV treatment. Data will be retrospectively collected from date of SOT/HSCT up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Intolerant participants identified based on physician judgment. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Viremia Clearance Before the End of Maribavir Treatment
CMV viremia clearance is defined as a negative Quantitative Polymerase Chain Reaction (PCR) result. A PCR result is defined as negative if CMV DNA is undetectable or below the lower limit of quantification as per local laboratory practice. Number of participants with the last CMV quantitative negative PCR result before the end of maribavir treatment will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Secondary outcomes (35)
Participants Categorized Based on Demographic Characteristics
Number of participants will be reported by their demographic characteristics (age, sex, past conditions and comorbidities).
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants Categorized by Transplant-Related Characteristics
Number of participants will be reported by transplant-related characteristics (type of transplant [HSCT/SOT]), transplant indication, donor and recipient CMV serostatus).
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants Characterized by Previous CMV Infection (Medical History)
Number of participants with prior CMV infections and clinical manifestations of CMV disease before Index CMV episode. Index CMV episode is defined as first CMV episode treated with maribavir.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants Characterized by Use of Prior Anti-CMV Treatment Strategies
Number of participants will be reported by treatments used (e.g. valganciclovir, ganciclovir, cidofovir, foscarnet or letermovir), by number and sequence of treatments/per CMV episode, by treatment strategy (e.g. prophylaxis, pre-emptive, treatment) before Index CMV episode. Index CMV episode is defined as first CMV episode treated with maribavir.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Duration of Each Treatment With Maribavir During Index and/or Post-Index CMV Episodes
Duration between start and end of treatment during Index and Post-index CMV episodes will be reported. Index CMV episode is defined as first CMV episode treated with maribavir. Post-index CMV episode is defined as first CMV recurrent episode after Index episode.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Number of Repeated Treatments With Maribavir During Index and/or Post-Index CMV Episodes
Number of repeated treatments with maribavir per CMV episode will be reported during index and/or post-index CMV episodes.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Maribavir Administration by Line of Therapy During Index and/or Post-Index CMV Episodes
Number of participants who received maribavir, as derived from the treatments sequence within a specific CMV episode, stratified by line of therapy.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Maribavir Dose Adjustments During Index and/or Post-Index CMV Episodes
Number of participants with maribavir dose adjustments and average dose adjustments will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
CMV Viral Load Prior to Maribavir Initiation, During Treatment With Maribavir, and After Discontinuation
Available CMV viral loads of interest prior to maribavir initiation, during treatment with maribavir, and after discontinuation will be reported for each maribavir treatment administered.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Reasons for Initiating and Discontinuing Maribavir Treatment During Index and/or Post-Index CMV Episodes
Number of participants categorized by their reasons for initiating and discontinuing maribavir treatment will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Place of Initiation of Maribavir Treatment
Number of participants categorized by place of initiation of maribavir treatment (Home/Hospital) will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Duration of Maribavir Treatment During Hospital In-patient Stay
Number of days of maribavir treatment during hospital in-patient stay will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants who Received Maribavir Monotherapy or Maribavir in Combination With Other Antivirals
Number of participants who received maribavir as monotherapy or in combination with other antivirals such as valganciclovir, ganciclovir, letermovir, cidofovir or foscarnet will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants who Received Concomitant Use of CMV-Specific IgG During Index and/or Post-Index CMV Episodes
Number of participants who received concomitant use of CMV-specific IgG during maribavir treatment will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Concomitant Use of Granulocyte Colony-Stimulating Factor (G-CSF)
Number of participants who received concomitant use of G-CSF during maribavir treatment will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Immunosuppressive Therapy Adjustments During Index and/or Post-Index CMV Episodes
Number of participants with immunosuppressive therapy adjustments during Index and/or Post-index CMV episodes will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to First CMV Viremia Clearance After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
Time to first CMV viremia clearance (first negative PCR) after initiation of maribavir will be reported. CMV viremia clearance is defined as a negative Quantitative PCR result. A PCR result is defined as negative if CMV DNA is undetectable or below the lower limit of quantification as per local laboratory practice.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to First CMV Viremia Control After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
Time to first CMV viremia control after initiation of maribavir will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With CMV Viremia Control per Week After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
Number of participants with CMV viremia control per week after initiation of maribavir will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Cumulative CMV Viremia Control at the End of Maribavir Treatment During Index and/or Post-Index CMV Episodes
Number of participants with cumulative CMV viremia control at the end of maribavir treatment will be reported. Viremia control is defined as at least a 1 log10 decrease in CMV DNA levels in blood, serum, or plasma, assessed through PCR, from the peak viral load before initiation of maribavir treatment and peak viral load at subsequent weeks of maribavir treatment.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Incidence of Tissue Invasive Disease During Index and/or Post-Index CMV Episodes
Percentage of participants with tissue invasive disease during Index and/or Post-index CMV episodes will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to Tissue Invasive Disease During Index and/or Post-Index CMV Episodes
Time to event of tissue invasive disease will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Incidence of CMV Syndrome Disease During Index and/or Post-Index CMV Episodes
Percentage of participants with CMV syndrome disease will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to CMV Syndrome Disease During Index and/or Post-Index CMV Episodes
Time to event of CMV syndrome disease will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Reduction or Resolution of CMV Disease/Syndrome at the End of Maribavir Treatment
Number of participants with reduction or resolution of CMV disease/syndrome at the end of maribavir treatment will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to Reduction or Resolution of CMV Disease/Syndrome After Maribavir Initiation
Time to reduction or resolution of CMV disease/syndrome after maribavir initiation will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Recurrent CMV Viremia (Post-Index CMV Episode)
Number of participants with asymptomatic and symptomatic recurrent CMV viremia (Post-index CMV episode) will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time From Maribavir Discontinuation to Next CMV Treatment and Anti-CMV Agent Used
Time from maribavir discontinuation to next CMV treatment and anti-CMV agent will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Anti-CMV Detected Resistance Mutations in the Study Population
Number of participants with detected anti-CMV resistance mutations prior to and after initiation of maribavir will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Anti-CMV Treatment Related Adverse Events of Special Interest (AESI)
Number of participants with Anti-CMV Treatment Related AESI will be reported. AESI will include myelosuppression (for example, leucopenia, thrombocytopenia, lymphopenia, neutropenia, etc.), nephrotoxicity and taste disturbances.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Abnormal Laboratory Parameters Related to AESI
Number of participants with abnormal laboratory parameters related to AESI will be reported. Laboratory parameters refer to complete blood count, glomerular filtration, etc.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With AESI Related to the Administration of Maribavir
Number of participants with AESI related to the administration of maribavir will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Outpatient Visit/Hospitalization Related to CMV Management
Number of participants with outpatient visit/hospitalization related to CMV management will be reported. Participants will be categorized by type of visit (outpatient, hospitalizations/emergency department visits), primary reason for the visit, CMV-related exams/procedures.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Length of Hospital Stay in Days for CMV-related Hospitalizations
Length of hospital stay in days for CMV -related hospitalizations will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Duration in Days of Critical Care against Non-critical Care
Duration in days of stay in critical care and non-critical care will be reported.
Measured: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start14 Oct 2024
- Primary completion4 Jul 2025
- Study completion4 Jul 2025
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
- 265 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
- NCT06615921
- Sponsor's protocol ID
- TAK-620-5010
- Status last verified
- Aug 2025
- First submitted
- 23 Aug 2024
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-country, Multi-center, Retrospective Chart Review to Describe the Use of Maribavir and Its Effectiveness in Patients With Post-Transplant Cytomegalovirus Infection/Disease
- ClinicalTrials.gov ID
- NCT06615921
- Acronym / sponsor ID
- TAK-620-5010
- Conditions
- Cytomegalovirus (CMV)
- Keywords
- Drug Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 265 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 4 Jul 2025 (actual)
- Study completion
- 4 Jul 2025 (actual)
- First posted
- 27 Sep 2024 (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 this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant. Other aims are to learn more about how maribavir is used in normal clinical routine, study the profiles of adults treated with maribavir, and what other treatments have been given, and describe healthcare resources used for CMV management.
Only data already available in the medical records of the participants will be reviewed and collected during this study.
Detailed description
This study will include two main periods of retrospective data collection from medical charts: the pre-index period and the post-index period. The index date is defined as the date of initiation of maribavir dosing, as documented in the medical records. The pre-index period covers the time from the transplant date to the index event, while the post-index period starts at the index event and ends at the date of chart abstraction, death, or loss to follow-up, whichever comes first.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants With CMV Infection Refractory | – | Other: No InterventionParticipants who had a CMV infection/disease that is refractory to treatment (with or without resistance). Data will be retrospectively collected from date of solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT) up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Participants will be considered as refractory if they show no change or increased viremia after at least 2 weeks of appropriately dosed antiviral therapy. |
| Participants With CMV Infection Intolerant | – | Other: No InterventionParticipants with CMV infection intolerant to anti-CMV treatment. Data will be retrospectively collected from date of SOT/HSCT up to the start date of chart abstraction, death or loss to follow-up, whichever comes first. Intolerant participants identified based on physician judgment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants who have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.
Key inclusion criteria (5 listed)
- Aged greater than or equal to (>=) 18 years at the time of consent or start of chart abstraction in case a consent waiver will be allowed as per local regulation.
- Received an HSCT/SOT.
- Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
- Initiated maribavir at least 4 months before the chart abstraction date (or at time of Central Ethics Committee [CEC]/Local Ethics Committee [LEC] submission as per local regulation).
- Participants with hospital medical chart available, who signed an informed consent form before starting any study procedures (unless waiver is allowed as per local regulation).
Key exclusion criteria (2 listed)
- Participants who do not provide informed consent, where consent is required per country regulations.
- Participants who participated to Clinical Trials investigating maribavir.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionThis is a non-interventional study. | Other | Participants With CMV Infection Intolerant, Participants With CMV Infection Refractory |
Primary outcome
Number of Participants With Viremia Clearance Before the End of Maribavir Treatment
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
CMV viremia clearance is defined as a negative Quantitative Polymerase Chain Reaction (PCR) result. A PCR result is defined as negative if CMV DNA is undetectable or below the lower limit of quantification as per local laboratory practice. Number of participants with the last CMV quantitative negative PCR result before the end of maribavir treatment will be reported.
35 secondary outcomes
Participants Categorized Based on Demographic Characteristics
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants Categorized by Transplant-Related Characteristics
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants Characterized by Previous CMV Infection (Medical History)
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants Characterized by Use of Prior Anti-CMV Treatment Strategies
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Duration of Each Treatment With Maribavir During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Number of Repeated Treatments With Maribavir During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Maribavir Administration by Line of Therapy During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Maribavir Dose Adjustments During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
CMV Viral Load Prior to Maribavir Initiation, During Treatment With Maribavir, and After Discontinuation
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Reasons for Initiating and Discontinuing Maribavir Treatment During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Place of Initiation of Maribavir Treatment
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Duration of Maribavir Treatment During Hospital In-patient Stay
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants who Received Maribavir Monotherapy or Maribavir in Combination With Other Antivirals
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants who Received Concomitant Use of CMV-Specific IgG During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Concomitant Use of Granulocyte Colony-Stimulating Factor (G-CSF)
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Immunosuppressive Therapy Adjustments During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to First CMV Viremia Clearance After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to First CMV Viremia Control After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With CMV Viremia Control per Week After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Cumulative CMV Viremia Control at the End of Maribavir Treatment During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Incidence of Tissue Invasive Disease During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to Tissue Invasive Disease During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Incidence of CMV Syndrome Disease During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to CMV Syndrome Disease During Index and/or Post-Index CMV Episodes
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Reduction or Resolution of CMV Disease/Syndrome at the End of Maribavir Treatment
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time to Reduction or Resolution of CMV Disease/Syndrome After Maribavir Initiation
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Recurrent CMV Viremia (Post-Index CMV Episode)
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Time From Maribavir Discontinuation to Next CMV Treatment and Anti-CMV Agent Used
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Anti-CMV Detected Resistance Mutations in the Study Population
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Anti-CMV Treatment Related Adverse Events of Special Interest (AESI)
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Abnormal Laboratory Parameters Related to AESI
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With AESI Related to the Administration of Maribavir
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Participants With Outpatient Visit/Hospitalization Related to CMV Management
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Length of Hospital Stay in Days for CMV-related Hospitalizations
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Duration in Days of Critical Care against Non-critical Care
Time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 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 8 Aug 2025.
- To obtain more information about this study, click this link.Link 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
45 sites in 10 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 45 sites in 10 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 5 inclusion and 2 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Germany, France, United Kingdom, Spain, Netherlands and 5 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?
Number of Participants With Viremia Clearance Before the End of Maribavir Treatment (time frame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months). 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 8 Aug 2025.