Clinical trial NCT06677892: A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium
Official title: Prospective, Non-interventional Study to Describe The Use of Maribavir and Its Effectiveness in Patients With Post-transplant Cytomegalovirus Infection/Disease in Line With Belgian Reimbursement Conditions (The MARIBEL Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cytomegalovirus (CMV)
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2024-11-07
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who had a CMV infection/disease after SOT/HSCT and who start maribavir, according to summary of product characteristics (SmPC) and in line with Belgian reimbursement criteria for maribavir will be included.

Brief summary: Cytomegalovirus (CMV) is a common virus that infects many people. It can cause serious illness in people with weak immune systems especially in those undergoing transplants. Maribavir is a medicine approved for treating CMV infection in adults after transplant.

The main aim of this study is to check the use of maribavir and learn how safe and effective in treating adults with CMV infection after transplant in Belgium in line with the Belgian reimbursement criteria.

During the study, a participant's data will be collected for 2 years. The study does not have fixed visits to the hospital, but it is recommended collect data from routine visits and contacts.


Eligibility criteria: Inclusion Criteria:

* Participant signed an informed consent form.
* Aged greater than or equal to (\>=) 18 years at the time of consent.
* Received an HSCT/SOT.
* Diagnosed with CMV infection/disease any time after the HSCT/SOT date.
* Starting maribavir for the first time and in line with the Belgian reimbursement criteria.

Exclusion Criteria:

• Participant treated with maribavir before the start of the study.

Primary outcomes:
measure: Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance
timeFrame: Up to 16 weeks
measure: Duration of Treatment
timeFrame: From treatment start to discontinuation of maribavir (up to 16 weeks)
measure: Time to Viral Clearance
timeFrame: From treatment start to achievement of viral clearance (up to 2 years)
measure: Percentage of Participants With Drug Resistance
timeFrame: Up to 2 years
measure: Number of Participants With Use of Maribavir in Daily Clinical Practice
timeFrame: Up to 16 weeks
measure: Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment
timeFrame: Up to 16 weeks
measure: Percentage of Participants With Recurrence After Maribavir Treatment
timeFrame: Up to 2 years
measure: Number of Participants With Treatment Related Adverse Events (AEs)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Hôpital Erasme
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires Saint-Luc
city: Edegem
country: Belgium
facility: UZA
city: Gent
country: Belgium
facility: UZGent
city: Jette
country: Belgium
facility: UZBrussel
city: Leuven
country: Belgium
facility: UZLeuven
city: Liège
country: Belgium
facility: CHU de Liège - site Sart Tilman
city: Yvoir
country: Belgium
facility: CHU UCL Namur - site Godinne
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: