A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection in Belgium (MARIBEL)

Takeda

Status: Enrolling

Conditions: Cytomegalovirus (CMV)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06677892

TAK-620-4014

Details and patient eligibility

About

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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

75 participants in 1 patient group

All Participants

Description:

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.

Treatment:

Other: No Intervention