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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 12 post-transplant for reporting.

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 more

Awards & 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

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