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Not yet recruitingNCT07706166MISP CMVUpdated Sep 25, 2026

Letermovir for R+ Study

A Phase 4 interventional study of Letermovir in Kidney Transplant and Liver Transplant, sponsored by University of Wisconsin, Madison. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by University of Wisconsin, Madison · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
146
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Kidney Transplant
  • Liver Transplant

Keywords

  • Moderate risk for CMV infection
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
146 participants (estimated)

Study arms

  • Experimental
    Receive letermovir

    Participants will take letermovir

    Drug: Letermovir

Interventions

  • DrugLetermovir

    1 tablet by mouth, once daily, for 84 days

05

What researchers measure

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.

    Time frame: 84 days

Secondary outcomes

  1. Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity

    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.

    Time frame: 84 days

06

Study locations

1 site
  • University of Wisconsin - Madison
    Madison, Wisconsin 53792, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07706166
Lead sponsor
University of Wisconsin, Madison
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jul 15, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2029 (estimated)
Completion
Sep 2029 (estimated)
Last update
Sep 25, 2026

Study contacts

Office of Clinical Research Department of Surgery
Contact
surgeryresearch@surgery.wisc.edu
608-576-0788
Margaret R Jorgenson, PharmD
Contact
mjorgenson@uwhealth.org
David Al-Adra, MD
principal investigator · University of Wisconsin, Madison

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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