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)

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Belgium
Hôpital Erasme
RECRUITING
Anderlecht
Institut Jules Bordet
RECRUITING
Anderlecht
Cliniques Universitaires Saint-Luc
RECRUITING
Brussels
UZA
RECRUITING
Edegem
UZGent
RECRUITING
Ghent
UZBrussel
RECRUITING
Jette
UZLeuven
RECRUITING
Leuven
CHU de Liège - site Sart Tilman
RECRUITING
Liège
CHU UCL Namur - site Godinne
RECRUITING
Yvoir
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 75
Treatments
All Participants
Participants with post-transplant CMV infection and/or disease that are refractory or intolerant to one or more prior therapies, who have undergone a solid organ transplant/ hematopoietic stem-cell transplantation (SOT/HSCT) and are treated with maribavir for the first time and in line with the Belgian reimbursement criteria, data will be collected and observed prospectively for up to 2 years.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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