Letermovir for R+ Study

An Interventional Study of Letermovir for Primary Prophylaxis of Cytomegalovirus Infection in Moderate Risk (R+) Abdominal Solid Organ Transplant Recipients

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07706166

Acronym

MISP CMV

Enrollment

146

Registered

2026-07-15

Start date

2026-09-01

Completion date

2029-09-01

Last updated

2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Transplant, Liver Transplant

Keywords

Moderate risk for CMV infection

Brief summary

The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV. Participants will take letermovir for 84 days.

Detailed description

This study is being done to see if letermovir prevents CMV reactivation in seropositive participants with a kidney or liver transplant.

Interventions

DRUGLetermovir

1 tablet by mouth, once daily, for 84 days

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+/R+ or D-/R+) * Adults who received a kidney transplant, liver transplant, or any combination thereof

Exclusion criteria

* Known contraindication to letermovir or its excipients * Current participation in another CMV related study * Unwilling or unable to participate in the study protocol

Design outcomes

Primary

Measure	Time frame	Description
Efficacy of letermovir as a prophylaxis of CMV	84 days	Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load \>1000 IU/mL.

Secondary

Measure	Time frame	Description
Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity	84 days	To be measured using the Eurofins-Viracor CMV inSIGHT™ T Cell Immunity testing. The test measures the strength of T cell responses to Cytomegalovirus (CMV) specific antigens.

Countries

United States

Contacts

CONTACTOffice of Clinical Research Department of Surgery

surgeryresearch@surgery.wisc.edu608-576-0788

CONTACTMargaret R Jorgenson, PharmD

mjorgenson@uwhealth.org

PRINCIPAL_INVESTIGATORDavid Al-Adra, MD

University of Wisconsin, Madison

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 27, 2026