Actively Recruiting
Open Label Trial of Tolerability and Efficacy of Oral Letermovir for CMV Prophylaxis Among Heart and Lung Transplant Recipients
Led by University of Pennsylvania · Updated on 2026-06-03
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the tolerability and effectiveness of letermovir for preventing cytomegalovirus (CMV) infection in adults who have received heart or lung transplants. The study compares letermovir with the standard valganciclovir treatment to see if letermovir offers similar protection against CMV, better tolerance with fewer side effects like neutropenia, and more accurate dosing related to kidney function. This is an open-label, phase 2 study sponsored by the University of Pennsylvania. Participants who receive letermovir for CMV prevention after heart or lung transplant will be followed prospectively for one year. The letermovir dose is typically 480 mg taken orally once daily, with dose adjustments if patients are also taking cyclosporine. The planned duration of prophylaxis may be up to 365 days depending on individual factors. The study also includes a comparison group who received valganciclovir prophylaxis in the two years prior to the study start. Throughout the study, participants will be monitored for CMV viral load and proper dosing adherence during the prophylaxis period and up to 180 days afterward. Researchers will also assess outcomes such as acute transplant rejection, development of CMV resistance, blood cell counts including neutropenia and thrombocytopenia, and any unplanned changes in other immunosuppressive medications. Safety labs and clinical evaluations will be conducted regularly, with a total follow-up extending up to one year post-prophylaxis.
CONDITIONS
Brief Title
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age is 18 years or older on the day of transplantation
- Recipient of heart or lung transplant
- Donor and/or recipient CMV seropositive within 1 year before transplantation
- Able to start oral CMV prophylaxis within 14 days (heart) or 28 days (lung) of transplantation
- Males at birth agree to use contraception during treatment and for 90 days after last dose
- Females at birth are not pregnant or breastfeeding and agree to contraception during treatment and for 90 days after last dose
- Persons of reproductive potential agree to abstinence or use acceptable birth control methods during treatment and for 90 days after last dose
You will not qualify if you...
- Prior solid organ transplant
- Dual organ transplantation
- Prior treated CMV infection
- Unknown CMV serostatus of donor or recipient
- Known allergy to letermovir or acyclovir formulations
- Severe kidney impairment (CrCl <10 mL/min) or on dialysis at enrollment
- Severe liver failure (Child-Pugh Class C)
- Very high liver enzymes or bilirubin above specified limits
- Moderate liver and moderate kidney insufficiency combined
- Neutropenia with absolute neutrophil count <1,500/microliter
- Severe thrombocytopenia with platelets <50,000/microliter
- Uncontrolled infection at enrollment
- Positive HIV antibody or hepatitis B surface antigen
- Active hepatitis C infection requiring certain treatments
- Pregnant, breastfeeding, or planning pregnancy during study period
- Planning to donate eggs or sperm during study period
- Recent or planned anti-CMV antibody or antiviral treatments
- Excessive prior ganciclovir or valganciclovir use before study drug initiation
- Participation in other investigational drug studies recently
- Previous participation in letermovir or CMV vaccine studies
- For unexposed subjects, any prior letermovir exposure
- Unable to take oral medications by day 14 post heart transplant or day 28 post lung transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 365 days depending on the organ transplanted and CMV status
Participants receive oral letermovir daily for CMV prophylaxis following heart or lung transplantation.
Regular visits as per clinical protocol during treatment period
Duration - 180 days after prophylaxis period
Participants are monitored for CMV viral load, adverse events, and other health outcomes after treatment ends.
Visits scheduled throughout the 180-day follow-up period
Trial Site Locations
Total: 1 location
1
Penn Medicine at the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
K
Kathryn Whitaker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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