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RECRUITING
NCT05708755
PHASE2

CMV Immunity Monitoring in Lung Transplant Recipients

Sponsor: NYU Langone Health

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine the safety and feasibility of using a laboratory test to guide duration of antiviral prophylaxis with valganciclovir (medication used to prevent viral infections) after lung transplant. The laboratory test, inSIGHT™ CMV T Cell Immunity Panel, measures patients' immune response to a common viral infection known as cytomegalovirus (CMV). The goal of this study will be to safely decrease how long patients need to take valganciclovir based on the results of the CMV T Cell Immunity Panel.

Official title: Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-09-13

Completion Date

2026-09

Last Updated

2025-07-30

Healthy Volunteers

No

Interventions

DEVICE

Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)

Whole blood assay that evaluates T cell (CD4 and CD8) responses to cytomegalovirus (CMV) antigens via intracellular cytokine staining (ICS).

DIAGNOSTIC_TEST

Donor-Derived Cell-Free DNA (dd-cfDNA) Assay

Determines the percentage of circulating cell-free DNA (cfDNA) in transplant recipients derived from donor grafts.

DRUG

Valganciclovir

Delivered as standard of care for post-lung transplant immunosuppression and infection prophylaxis. Started on the first day post-transplant at a standard dose of 900 mg daily and continued for 12 months. Dose adjustments may be necessary based on renal function and/or adverse effects (e.g. neutropenia). Dose adjustments are standard based on package insert recommendations.

Locations (1)

NYU Langone Health

New York, New York, United States