Letermovir Prophylaxis for Cytomegalovirus Infection in Heart Transplant Recipients

Recruiting at 1 trial location

Overseen By David R Snydman, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Tufts Medical Center

Disqualifiers: HIV, Severe hepatic insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-6 months

31 Participants Needed

Trial Summary

What is the purpose of this trial?

This is an open label trial in which letermovir will be given as prophylaxis for the prevention of CMV infection and disease to all heart transplants who are at risk for cytomegalovirus. The study will compare a 30 patient prospective cohort to a retrospective cohort of 374 heart transplant recipients for the rates of neutropenia. In addition, the tolerability of letermovir will be assessed in this population.

Eligibility Criteria

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

I have signed the consent form and can attend all follow-up visits.

I had a heart transplant and either I or my donor was not CMV negative.

Not enrolled in competing clinical trials

Exclusion Criteria

Hypersensitivity to letermovir

Patients who do not survive 72 hours post transplant

My liver is not working well (severe issues).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive letermovir 480 mg daily for CMV prophylaxis for either 3 or 6 months depending on CMV risk category

3-6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of T cell immunity and adverse events

12 months

Treatment Details

Interventions

• Letermovir

Trial Overview The trial tests Letermovir as a preventive measure against CMV infection in heart transplant recipients. It compares outcomes of a new group of 30 patients with those from a past group of 374 patients, focusing on rates of neutropenia and drug tolerability.

Participant Groups

Group I: single arm Experimental Treatment 1 Intervention

Letermovir 480 mg daily for cmv prophylaxis

Letermovir is already approved in United States, European Union for the following indications:

Approved in United States as Prevymis for:

• 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-])

Approved in European Union as Prevymis for:

• 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-])

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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