NCT07706166

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P50-P75 for phase_4

Timeline
37mo left

Started Aug 2026

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 15, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2029

Last Updated

July 15, 2026

Status Verified

July 1, 2026

Enrollment Period

3 years

First QC Date

July 9, 2026

Last Update Submit

July 9, 2026

Conditions

Kidney TransplantLiver Transplant

Keywords

Moderate risk for CMV infection

Outcome Measures

Primary Outcomes (1)

  • Efficacy of letermovir as a prophylaxis of CMV

    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.

    84 days

Secondary Outcomes (1)

  • Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity

    84 days

Study Arms (1)

Receive letermovir

EXPERIMENTAL

Participants will take letermovir

Drug: Letermovir

Interventions

LetermovirDRUG

1 tablet by mouth, once daily, for 84 days

Receive letermovir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Interventions

letermovir

Study Officials

  • David Al-Adra, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Office of Clinical Research Department of Surgery

CONTACT

608-576-0788surgeryresearch@surgery.wisc.edu

Margaret R Jorgenson, PharmD

CONTACT

mjorgenson@uwhealth.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2026

First Posted

July 15, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

August 1, 2029

Last Updated

July 15, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)