RecruitingPhase 4NCT05626530

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

A Pilot Trial of the Tolerability and Clinical Effectiveness of Letermovir When Used for Secondary Prophylaxis to Prevent Recurrent Cytomegalovirus Disease in Solid Organ Transplant Recipients


Sponsor

Tufts Medical Center

Enrollment

25 participants

Start Date

Feb 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a research study to test the tolerability and clinical effectiveness of the study drug, Letermovir (LET), when used as secondary prophylaxis following treatment of Cytomegalovirus (CMV) infection and disease in a solid organ transplant recipient. This study is an open label trial in which Letermovir will be prescribed to prevent the recurrence of CMV infection and disease in a solid organ transplant recipient following treatment of CMV infection or disease.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests letermovir, an antiviral pill taken once daily, as a way to prevent cytomegalovirus (CMV) from coming back in solid organ transplant recipients (heart, kidney, or liver) who have already been treated for a CMV infection or disease. CMV is a common virus that can cause serious illness in transplant patients because their immune system is suppressed, and preventing recurrence is a major challenge. Adult transplant recipients (over 18) who have completed CMV treatment and whose doctor believes they need preventive therapy are eligible, provided they have adequate kidney and liver function and are not on dialysis. Participation involves taking letermovir 480 mg once daily for 60 days, with blood tests to monitor immune response, and follow-up visits for 4 months after stopping the drug to check for relapse. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLetermovir

Open label 480 mg given daily for 60 days


Locations(1)

Tufts Medical Center-Division of Geographic Medicine and Infectious Diseases

Boston, Massachusetts, United States

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NCT05626530


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