About this trial
This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient.
This study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.
Eligibility criteria
Qualifiers
Adult (> 18 years old) solid organ transplant recipients (heart, kidney or liver patients) recovering from treated CMV disease in whom the clinician deems that the patient need secondary prophylaxis and in whom written informed consent is obtained.
Patient able to participate with follow up for 6 months
Not enrolled in competing clinical trials
Disqualifiers
Patients with creatinine clearance less than 10 ml per min at time of enrollment
Hypersensitivity to letermovir or has a CMV isolate which is known to be resistant to letermovir based on prior testing
On CVVH or renal dialysis at the time of enrollment
Has Child Pugh Class C severe hepatic insufficiency at screening.
Trial design
Treatments tested in this trial
- Letermovir