Recruiting
Phase 2
Phase 3

Letermovir vs. Valganciclovir

Sponsor:

Columbia University

Code:

NCT07079735

Conditions

CMV Viremia

Heart Transplant Infection

Heart Transplant Failure and Rejection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Letermovir

Valganciclovir

Study Details

Brief summary:

The purpose of this study is to compare the safety and efficacy of letermovir with valganciclovir for prevention of Cytomegalovirus (CMV) viremia in moderate to high risk serostatus heart transplant recipients.

Conditions

CMV Viremia

Heart Transplant Infection

Heart Transplant Failure and Rejection

Study ID

NCT07079735

Start date

Sep 12, 2025

Status verified date

Sep, 2025

Completion date

Jan 17, 2029

Anticipated

Primary completion date

Jan 17, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patients who are >18 years of age who have received a heart transplant and have not started their CMV prophylaxis regimen will be included.

Exclusion Criteria:

History of or suspected CMV disease within 6 months prior is excluded.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Letermovir

Patients with moderate to high risk CMV risk will get letermovir for prophylaxis for 6 months for moderate risk and 1 year for high risk

active comparator: Valganciclovir

Patients with moderate to high risk CMV risk will get valganciclovir for prophylaxis for 6 months for moderate risk and 1 year for high risk. This is standard of care

no intervention: No treatment

Low risk CMV patients who do not have an indication for CMV prophylaxis will be monitored

Interventions

Letermovir

CMV prophylaxis

Valganciclovir

Standard therapy for CMV prophylaxis

Primary outcome measure

  • Occurrence of leukopenia [ Time Frame: During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy) ]
  • Occurrence of neutropenia [ Time Frame: During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk from start of therapy) ]

Central Contacts and Locations

Central contacts

Afsana Rahman, MD

2123054600ar3262@cumc.columbia.edu

Locations

NYP-Weill Cornell

Recruiting

New York, New York, United States, 10021

Contacts

David Majure, MD

6469629062dtm9002@med.cornell.edu

Principal Investigator:

David Majure, MD

Columbia University/NYP Milstein Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Afsana Rahman, MD

2123054600ar3262@cumc.columbia.edu

Principal Investigator:

Afsana Rahman, MD

More Information

Sponsor

Columbia University

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Columbia University on 2025-09-25.