Actively Recruiting
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
Led by University of Pennsylvania · Updated on 2025-05-21
80
Participants Needed
1
Research Sites
123 weeks
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
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
CONDITIONS
Official 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 a heart or lung transplant
- Donor or recipient is CMV seropositive (positive IgG) within 1 year before transplantation
- Able to start oral CMV prophylaxis within 14 days after heart transplant or within 28 days after lung transplant
- Males at birth agree to use contraception during treatment and for 90 days after last dose and avoid sperm donation
- Females at birth are not pregnant or breastfeeding and agree to contraception during treatment and for 90 days after last dose
- Males or females of reproductive potential agree to use acceptable birth control or true abstinence from consent through 90 days after last dose
You will not qualify if you...
- Previous solid organ transplant
- Dual organ transplantation
- Previous treated CMV infection
- Unknown CMV status of donor or recipient
- Known allergy to letermovir or acyclovir ingredients
- Creatinine clearance less than 10 mL/min or on renal replacement therapy at enrollment
- Severe liver failure (Child-Pugh Class C) at enrollment
- Liver enzymes (AST or ALT) more than 5 times normal or bilirubin more than 2.5 times normal, unless repeat labs are normal
- Both moderate liver and moderate kidney impairment
- Low neutrophil count (less than 1500/microliter) at enrollment
- Severe low platelet count (less than 50,000/microliter) at enrollment
- Uncontrolled infection at enrollment
- Positive HIV antibody test or positive hepatitis B surface antigen within 90 days before enrollment
- Positive hepatitis C antibody and detectable RNA within 90 days before enrollment needing certain antiviral treatments
- Pregnant, expecting to conceive, breastfeeding, or planning to breastfeed during treatment and 90 days after
- Planning to donate eggs or sperm during treatment and 90 days after
- Received or plans to receive certain anti-CMV treatments within 30 days before or during study
- Heart transplant recipients who had more than 14 days of certain CMV drugs before study drug or plans to receive during study
- Lung transplant recipients who had more than 28 days of certain CMV drugs before study drug or plans to receive during study
- Participation in other investigational drug studies within 28 days or 5 half-lives of the drug
- Previous participation in this study or any study involving letermovir
- Participation or planned participation in CMV vaccine or investigational CMV agent studies
- For unexposed subjects, any prior letermovir exposure
- Unable to take oral medications by 14 days after heart transplant or 28 days after lung transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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