Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Pennsylvania
About this trial
Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients. The study hypotheses are:
1. Letermovir prophylaxis will be associated with similar rates of CMV infection as valganciclovir among heart and lung transplant recipients 2. Letermovir will be better tolerated than valganciclovir for CMV prophylaxis in heart and lung transplant recipients, with a higher proportion of days of completed therapy with correct dosing during the planned prophylaxis period 3. Letermovir will have a lower rate of neutropenia than valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients 4. Incorrect renal dosing will occur less frequently with letermovir than with valganciclovir when used for CMV prophylaxis in heart and lung transplant recipients
Eligibility criteria
Qualifiers
Age is >=18 years on the day of transplantation.
Heart or Lung transplant recipient.
Donor and/or Recipient CMV seropositive (defined by positive IgG) within 1 year prior to transplantation.
Able to start oral CMV prophylaxis within 14 days (heart graft recipients) or 28 days (lung graft recipients) of transplantation.
Disqualifiers
Any prior solid organ transplant.
Dual organ transplantation.
Prior treated CMV infection.
Unknown CMV serostatus of the donor or recipient.
Trial design
Treatments tested in this trial
- Letermovir 480 MG [Prevymis]
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Pennsylvania
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov