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NCT Number: NCT07706166

Letermovir for R+ Study

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.

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Key information

Conditions

Kidney Transplant Liver Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Letermovir

Drug

1 tablet by mouth, once daily, for 84 days

Primary outcomes

  1. Efficacy of letermovir as a prophylaxis of CMV

    Time frame: 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 outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Margaret R Jorgenson, PharmD

CONTACT

[email protected]

Office of Clinical Research Department of Surgery

CONTACT

[email protected]

608-576-0788

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

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

Acronym: MISP CMV

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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