Evaluating Maribavir for Cytomegalovirus Infection in Transplant Patients in Belgium
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)
This study is testing if a drug called maribavir is safe and effective for adults with cytomegalovirus infection after they have had a stem cell or organ transplant in Belgium.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Locations | 9 sites (Anderlecht and 8 other locations) |
| Trial ID | NCT06677892 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of maribavir in treating adults with cytomegalovirus (CMV) infection following hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT) in Belgium. Participants will have their data collected over a two-year period, primarily during routine medical visits, to evaluate the drug's performance in accordance with Belgian reimbursement criteria. The study focuses on individuals starting maribavir treatment for the first time, ensuring that the findings are relevant to new patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have undergone HSCT or SOT and are newly diagnosed with CMV infection.
Not a fit: Patients who have previously been treated with maribavir will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective treatment option for adults suffering from CMV infections post-transplant.
How similar studies have performed: While this approach is based on an existing treatment, the specific observational study design in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Anderlecht and 8 other locations
- Hôpital Erasme — Anderlecht, Belgium (Recruiting)
- Institut Jules Bordet — Anderlecht, Belgium (Recruiting)
- Cliniques Universitaires Saint-Luc — Brussels, Belgium (Recruiting)
- Uza — Edegem, Belgium (Recruiting)
- UZGent — Ghent, Belgium (Recruiting)
- UZBrussel — Jette, Belgium (Recruiting)
- UZLeuven — Leuven, Belgium (Recruiting)
- CHU de Liège - site Sart Tilman — Liège, Belgium (Recruiting)
- CHU UCL Namur - site Godinne — Yvoir, Belgium (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.