Clinical trial NCT06615921: A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus (CMV)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-09-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who have been diagnosed with Post-Transplant Cytomegalovirus infection/disease in several European countries.

Brief 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. 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.

Eligibility criteria: Inclusion criteria:

* 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).

Exclusion criteria:

* Participants who do not provide informed consent, where consent is required per country regulations.
* Participants who participated to Clinical Trials investigating maribavir.

Primary outcomes:
measure: Number of Participants With Viremia Clearance Before the End of Maribavir Treatment
timeFrame: 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:
measure: Participants Categorized Based on Demographic Characteristics
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants Categorized by Transplant-Related Characteristics
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants Characterized by Previous CMV Infection (Medical History)
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants Characterized by Use of Prior Anti-CMV Treatment Strategies
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Duration of Each Treatment With Maribavir During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Number of Repeated Treatments With Maribavir During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Maribavir Administration by Line of Therapy During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Maribavir Dose Adjustments During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: CMV Viral Load Prior to Maribavir Initiation, During Treatment With Maribavir, and After Discontinuation
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Reasons for Initiating and Discontinuing Maribavir Treatment During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Place of Initiation of Maribavir Treatment
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Duration of Maribavir Treatment During Hospital In-patient Stay
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants who Received Maribavir Monotherapy or Maribavir in Combination With Other Antivirals
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants who Received Concomitant Use of CMV-Specific IgG During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Concomitant Use of Granulocyte Colony-Stimulating Factor (G-CSF)
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Immunosuppressive Therapy Adjustments During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Time to First CMV Viremia Clearance After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Time to First CMV Viremia Control After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With CMV Viremia Control per Week After Initiation of Maribavir During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Cumulative CMV Viremia Control at the End of Maribavir Treatment During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Incidence of Tissue Invasive Disease During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Time to Tissue Invasive Disease During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Incidence of CMV Syndrome Disease During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Time to CMV Syndrome Disease During Index and/or Post-Index CMV Episodes
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Reduction or Resolution of CMV Disease/Syndrome at the End of Maribavir Treatment
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Time to Reduction or Resolution of CMV Disease/Syndrome After Maribavir Initiation
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Recurrent CMV Viremia (Post-Index CMV Episode)
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Time From Maribavir Discontinuation to Next CMV Treatment and Anti-CMV Agent Used
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Anti-CMV Detected Resistance Mutations in the Study Population
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Anti-CMV Treatment Related Adverse Events of Special Interest (AESI)
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Abnormal Laboratory Parameters Related to AESI
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With AESI Related to the Administration of Maribavir
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Participants With Outpatient Visit/Hospitalization Related to CMV Management
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Length of Hospital Stay in Days for CMV-related Hospitalizations
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
measure: Duration in Days of Critical Care against Non-critical Care
timeFrame: From transplantation date until start of chart abstraction or date of death from any cause, whichever comes first, up to approximately 32 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna Dept. of Nephrology and Dialysis
city: Copenaghen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - CHU BORDEAUX
city: Dijon
country: France
facility: Department of Nephrology, University Hospital of Dijon
city: Lille
country: France
facility: Hopital Claude Huriez CHRU Lille
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: CHU De Nice Hopital Pasteur 2
city: Paris
country: France
facility: Hopital Saint-Louis AP-HP Pitor
city: Paris
country: France
facility: APHP, Sorbonne University, Pitie Salpetriere Hospital
city: Paris
country: France
facility: Necker-Enfants Malades Hospital
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg
city: Toulouse
country: France
facility: Toulouse University Hospital - Hopital de Rangueil
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen
city: Berlin
country: Germany
facility: Charite, Dept of Nephrology
city: Essen
country: Germany
facility: Clinic for Infectiology - Essen
city: Greifswald
country: Germany
facility: University Hospital Greifswald
city: Hamburg
country: Germany
facility: Clinic for stem cell transplantation - Hamburg (UKE)
city: Hannover
country: Germany
facility: Hannover Medical School - Resp Medicine
city: Leipzig
country: Germany
facility: Uniklinik Leipzig
city: Mainz
country: Germany
facility: Medicine Clinic of Johannes Gutenberg - Mainz university
city: Munich
country: Germany
facility: Ludwig-Maximilians University (LMU) Hospital
city: Ulm
country: Germany
facility: University of Ulm
city: Wurzburg
country: Germany
facility: Universitaetsklinikum Wuerzburg
city: Roma
country: Italy
facility: Policlinico Gemelli - Roma
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cancer Institute
city: Utrecht
country: Netherlands
facility: UMC Utrecht (Hematology)
city: Belgrade
country: Serbia
facility: University of Belgrade
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Bilbao
country: Spain
facility: Hospital de Cruces
city: Granada
country: Spain
facility: Hospital Virgen de las Nieves
city: Las Palmas
country: Spain
facility: Hospital Dr. Negrin
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Puerta del Hierro
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham
city: Cambridge
country: United Kingdom
facility: Royal Papworth Hospital (Cambridge)
city: London
country: United Kingdom
facility: University College Hospital London
city: London
country: United Kingdom
facility: Kings College Hospital (London)
city: London
country: United Kingdom
facility: Royal Marsden Hospital (London)
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Newcastle
country: United Kingdom
facility: Freeman Hospital Newcastle upon Tyne
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS trust (Queens Medical Centre)
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS FT
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: