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Antiviral
CMV Immunity Monitoring for Lung Transplant Complications
Phase 2
Recruiting
Led By Luis Angel, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 12 post-transplant
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if lab test results can safely reduce the time patients need to take a medication to prevent viral infections after a lung transplant.
Who is the study for?
This trial is for individuals who have had a lung transplant at NYU Langone Health, possess immunity to CMV (R+), and can consent to participate. It's not open to those who received anti-thymocyte globulin, underwent perioperative desensitization, or are pregnant/breastfeeding.
What is being tested?
The study tests if monitoring the immune response to cytomegalovirus (CMV) using the inSIGHT™ CMV T Cell Immunity Panel can guide how long patients take valganciclovir after a lung transplant, potentially reducing treatment duration.
What are the potential side effects?
Valganciclovir may cause side effects like diarrhea, nausea, vomiting, fever, shaking chills; potential risks of blood cell count changes leading to infections or anemia; and it could affect kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 12 post-transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 12 post-transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
CMV Viremia-Free Survival
Secondary study objectives
Incidence of Aspergillus Infection
Incidence of Bacterial Pneumonia
Incidence of CMV Viremia
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lung Transplant RecipientsExperimental Treatment3 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valganciclovir
2019
Completed Phase 4
~2160
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,327 Total Patients Enrolled
Viracor EurofinsUNKNOWN
Luis Angel, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
67 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone treatment to reduce my body's reaction to surgery.I had a lung or multi-organ transplant at NYU Langone Health.I am receiving anti-thymocyte globulin for immune suppression.
Research Study Groups:
This trial has the following groups:- Group 1: Lung Transplant Recipients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.