Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTufts Medical Center

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

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators