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NCT05708755 · ClinicalTrials.gov registry record · Phase 2
CMV Immunity Monitoring in Lung Transplant Recipients
A Phase 2 study of Lung Transplant; Complications, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT05708755: Recruiting Phase 2 study of Lung Transplant; Complications, sponsored by NYU Langone Health.
NCT05708755 is a Phase 2 study of Lung Transplant; Complications that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 50 participants, below the 568-participant average among 6 other Lung Transplant; Complications trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05708755, a Phase 2 study of Lung Transplant; Complications, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Defined as the the time from lung transplant until the first detection of CMV DNA in patients' blood.
Conditions Studied
Interventions
- DEVICE Cytomegalovirus T Cell Immunity Panel (CMV-TCIP)
- DIAGNOSTIC_TEST Donor-Derived Cell-Free DNA (dd-cfDNA) Assay
- DRUG Valganciclovir
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-09-13 |
| Est. Completion | 2026-09 |
| Phase | Phase 2 |
What NCT05708755 shows while recruiting
NCT05708755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 568-participant average among 6 other Lung Transplant; Complications trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Lung Transplant; Complications appearing as the primary indexed condition, and to 3 interventions - of which Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) is the first listed.
NCT05708755 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT05708755 about?
NCT05708755 is a clinical study titled "CMV Immunity Monitoring in Lung Transplant Recipients". 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 patien...
What is the current status of trial NCT05708755?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2024-09-13. Estimated completion is 2026-09.
What conditions does trial NCT05708755 study?
This clinical trial studies the following conditions: Lung Transplant; Complications.
What interventions are being tested in trial NCT05708755?
The interventions under investigation include: Cytomegalovirus T Cell Immunity Panel (CMV-TCIP) (DEVICE), Donor-Derived Cell-Free DNA (dd-cfDNA) Assay (DIAGNOSTIC_TEST), Valganciclovir (DRUG).
Who is sponsoring clinical trial NCT05708755?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05708755 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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