Letermovir Prophylaxis for Cytomegalovirus Infection in Heart Transplant Recipients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests letermovir (Prevymis) to prevent cytomegalovirus (CMV) infections in heart transplant patients at risk of CMV. Researchers aim to assess the drug's effectiveness and patient tolerance, particularly regarding side effects like neutropenia (a drop in white blood cells). The trial compares new data from 30 patients with past data from 374 transplant recipients. Heart transplant recipients who are not CMV donor and recipient negative may be suitable for this study. As a Phase 4 trial, this research focuses on understanding how the already FDA-approved and effective treatment benefits more patients.
Do I have to stop taking my current medications for this trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor to get a clear answer.
What is the safety track record for letermovir?
Research has shown that letermovir is already approved to prevent cytomegalovirus (CMV) in individuals who have undergone certain transplants, such as kidney and stem cell transplants. This indicates it is generally safe and well-tolerated in these groups. Studies suggest it could also be a safe and effective option for preventing CMV infections in heart transplant patients.
This trial is in Phase 4, indicating that letermovir has already undergone safety testing in earlier phases. Phase 4 focuses more on the treatment's effectiveness and seeks to identify any rare side effects. Letermovir has passed many safety checks already. However, participants should report any side effects to the study team.12345Why are researchers enthusiastic about this study treatment?
Letermovir is unique because it offers a targeted approach to preventing cytomegalovirus (CMV) infections in heart transplant recipients. Unlike current treatments like ganciclovir or valganciclovir, which can have significant side effects including bone marrow suppression, letermovir works by inhibiting the CMV DNA terminase complex, reducing the risk of these complications. Researchers are excited about letermovir because it has shown promise in being both effective and better tolerated, potentially leading to improved outcomes and quality of life for transplant patients.
What evidence suggests that letermovir is effective for preventing cytomegalovirus infection in heart transplant recipients?
Previous studies have shown that letermovir effectively prevents cytomegalovirus (CMV) infections in heart transplant patients. Specifically, 92.3% of patients completed their letermovir treatment without contracting CMV after their heart transplant. Research indicates that letermovir is generally well-tolerated and offers protection comparable to other treatments. This medication is already approved for preventing CMV, demonstrating its effectiveness in stopping these infections in individuals with weakened immune systems. In this trial, participants will receive letermovir as a single-arm treatment for CMV prophylaxis.24678
Are You a Good Fit for This Trial?
This trial is for adults aged 18-70 who have recently received a heart transplant and are at risk for cytomegalovirus, but not HIV positive or on dialysis. They mustn't be allergic to letermovir, participating in other clinical trials with investigational drugs, or planning to donate eggs/sperm within 90 days after the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive letermovir 480 mg daily for CMV prophylaxis for either 3 or 6 months depending on CMV risk category
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of T cell immunity and adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Letermovir
Letermovir is already approved in United States, European Union for the following indications:
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tufts Medical Center
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University