NYU Langone Health
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.
Lung Transplant; Complications
Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
Valganciclovir
Phase 2
| Study Type : | Interventional |
| Estimated Enrollment : | 50 participants |
| Masking : | None (Open Label) |
| Primary Purpose : | Prevention |
| Official Title : | Cytomegalovirus T Cell Immunity and Antiviral Prophylaxis Minimization in Lung Transplant Recipients |
| Actual Study Start Date : | April 2024 |
| Estimated Primary Completion Date : | December 2024 |
| Estimated Study Completion Date : | December 2025 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Lung Transplant Recipients Lung transplant recipients with pre-transplant serological immunity to CMV. CMV-TCIP will be measured every 3 months post-transplant with antiviral prophylaxis discontinued when threshold is exceeded. |
Device: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) Diagnostic Test: Donor-Derived Cell-Free DNA (dd-cfDNA) Assay Drug: Valganciclovir |
| Ages Eligible for Study: | 18 Years to 99 Years |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
NYU Langone Health
New York, New York, United States, 10016