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Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients

Cytomegalovirus Infections Clinical Trial

Official title:
Open Label Trial of Tolerability and Efficacy of Oral Letermovir for CMV Prophylaxis Among Heart and Lung Transplant Recipients

Clinical Trial Summary

Open label study to determine tolerability and efficacy of letermovir for CMV prophylaxis in heart and lung transplant recipients and compare it to the efficacy of valganciclovir historical controls. 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

Clinical Trial Description

This study is a prospective cohort design. Subjects exposed to letermovir for CMV prophylaxis following heart or lung transplantation will be compared with those who received standard valganciclovir prophylaxis in the two years before the study began (referred to as the "pre-intervention" period). The goal is to evaluate the efficacy and tolerability of letermovir. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06066957
Study type Interventional
Source University of Pennsylvania
Contact Kathryn Whitaker, MD
Phone 267-581-2135
Email Kathryn.Whitaker@pennmedicine.upenn.edu
Status Recruiting
Phase Phase 2
Start date April 4, 2024
Completion date August 15, 2026
View Details
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