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Antiviral

CMV Immunity Monitoring for Lung Transplant Complications

Phase 2

Waitlist Available

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

CMV Viremia-Free Survival

Secondary outcome measures

Incidence of Aspergillus Infection

Incidence of Bacterial Pneumonia

Incidence of CMV Viremia

+4 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,692 Total Patients Enrolled

Viracor EurofinsUNKNOWN

Luis Angel, MDPrincipal InvestigatorNYU Langone Health

3 Previous Clinical Trials

67 Total Patients Enrolled

Media Library

Valganciclovir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05708755 — Phase 2

Lung Transplant Complications Research Study Groups: Lung Transplant Recipients

Lung Transplant Complications Clinical Trial 2023: Valganciclovir Highlights & Side Effects. Trial Name: NCT05708755 — Phase 2

Valganciclovir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708755 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could participants over forty years of age take part in this trial?

"In line with this trial's inclusion criteria, the lower age limit for participants is 18 and the upper boundary is 99."

Answered by AI

What risks do individuals face when undergoing a lung transplant?

"Our team at Power has rated the safety of Lung Transplant Recipients a 2 on their scale, as this is only Phase 2. This implies that there are some data points verifying its safety but none confirming efficacy."

Answered by AI

Is this investigation presently seeking participants?

"According to clinicaltrials.gov, this trial is not currently accepting participants. The initial posting dates back to April 1st 2023 and the most recent modification was made on January 24th 2023. Although there are no immediate opportunities for enrolment in this study, 12 other medical trials are actively seeking volunteers at present."

Answered by AI

Are the requirements for this trial compatible with my credentials?

"This clinical trial is recruiting 50 individuals aged 18 to 99 that have experienced complications from a lung transplant, or multi-organ transplant with at least one lung originating from NYU Langone Health. The necessary prerequisites for admission include documented serological immunity to CMV (R+), and the ability and desire to provide informed consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CMV Immunity Monitoring in Lung Transplant Recipients

2024. "CMV Immunity Monitoring in Lung Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05708755.

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