Maribavir Use & Effectiveness in the Real-World (ARISE), version 1.0
Research type
Research Study
Full title
A Multi-country, Multi-center, Retrospective Chart Review to Describe the Use of Maribavir and its Effectiveness in Patients with Post-Transplant Cytomegalovirus infection/disease
IRAS ID
341016
Contact name
Karl Stuart Peggs
Contact email
Sponsor organisation
Takeda Pharmaceuticals International AG
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Cytomegalovirus (CMV) is one of the most common type of viruses affecting humans, with an estimated worldwide prevalence of 83% among the general population. CMV infection in healthy individuals is generally mild, but immunocompromised patients may develop CMV disease and more serious symptoms. CMV infection is a frequent possible complication for patients who underwent solid organ transplant (SOT) or hematopoietic stem cell transplant (HSCT).
Maribavir is a recently approved antiviral drug for the treatment of CMV infection and/or CMV disease in patients with suboptimal response to currently used antivirals. The benefits of maribavir have been demonstrated in a phase 3 trial, but there is limited clinical experience with this new antiviral drug.This non-interventional study will be conducted to investigate the use, effectiveness and safety of maribavir in Austria, Denmark, France, Germany, Italy, Netherlands, Serbia, Spain, Switzerland, and United Kingdom (UK). The main objective of the study is to describe the effectiveness of maribavir in clearing the presence of CMV in patients’ blood. Documenting early experiences with maribavir in a real-world setting will help characterize the clinical profile of this new treatment and inform future post-transplant CMV treatment guidelines.
The study is a retrospective study that will use existing data from medical records, dating back to patient transplant date, available at transplant centres in UK. Patients are eligible if they had a CMV infection or disease after HSCT/SOT and have been treated with maribavir during the eligibility period. A total of 150 patients is planned to be enrolled in the study. All patient data will be pseudonymised to preserve confidentiality. In addition to utilising secondary data from routine clinical care, we foresee value in collecting clinicians’ perspective on routine care of transplanted patients with CMV infections to better contextualize the data collected during the conduct of the study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
24/YH/0229
Date of REC Opinion
5 Nov 2024
REC opinion
Further Information Favourable Opinion