A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No Intervention.
- Who it may be relevant to
- Registry conditions: Cytomegalovirus (CMV). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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)
Overview
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.
Interventions
- Other No Intervention
This is non-interventional study.
Primary outcome measures
- Number of Participants With Effectiveness of Maribavir on CMV Viremia Clearance [Time frame: Up to 16 weeks]
- Duration of Treatment [Time frame: From treatment start to discontinuation of maribavir (up to 16 weeks)]
- Time to Viral Clearance [Time frame: From treatment start to achievement of viral clearance (up to 2 years)]
- Percentage of Participants With Drug Resistance [Time frame: Up to 2 years]
- Number of Participants With Use of Maribavir in Daily Clinical Practice [Time frame: Up to 16 weeks]
- Number of Participants Who Have Refractory CMV Infection With/Without Resistance, or Intolerance to a Previous CMV Treatment [Time frame: Up to 16 weeks]
- Percentage of Participants With Recurrence After Maribavir Treatment [Time frame: Up to 2 years]
- Number of Participants With Treatment Related Adverse Events (AEs) [Time frame: Up to 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 9 centers
- Hôpital Erasme — Anderlecht
- Institut Jules Bordet — Anderlecht
- Cliniques Universitaires Saint-Luc — Brussels
- UZA — Edegem
- UZGent — Ghent
- UZBrussel — Jette
- UZLeuven — Leuven
- CHU de Liège - site Sart Tilman — Liège
- … and 1 more center
Identifiers
NCT: NCT06677892 · TAK-620-4014