NCT07079735

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
33mo left

Started Sep 2025

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2025Jan 2029

First Submitted

Initial submission to the registry

July 9, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 17, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 17, 2029

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

2.3 years

First QC Date

July 9, 2025

Last Update Submit

September 22, 2025

Conditions

CMV ViremiaHeart Transplant InfectionHeart Transplant Failure and Rejection

Outcome Measures

Primary Outcomes (2)

  • Occurrence of leukopenia

    Number of patients with leukopenia (white blood cell count \<3000 cells µL)

    During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)

  • Occurrence of neutropenia

    Number of patients with neutropenia (absolute neutrophil count \<1500 cells/µL)

    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)

Secondary Outcomes (3)

  • Number of patients with any detectable CMV viremia after initiation of CMV prophylaxis

    6 months after initiation of CMV prophylaxis

  • Number of patients with any detectable CMV viremia while on CMV prophylaxis

    During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk patients)

  • Number of patients with any detectable CMV viremia after completing CMV prophylaxis

    Within 6 months after completing CMV prophylaxis

Other Outcomes (2)

  • Percent of CD4 and CD8 T cells that respond to CMV antigen

    6 months to 1 year after initiating CMV prophylaxis

  • Viral load of the torque teno virus (TTV)

    6 months to 1 year after initiating CMV prophylaxis

Study Arms (3)

Letermovir

EXPERIMENTAL

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

Drug: Letermovir

Valganciclovir

ACTIVE COMPARATOR

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

Drug: Valganciclovir

No treatment

NO INTERVENTION

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

Interventions

LetermovirDRUG

CMV prophylaxis

Letermovir
ValganciclovirDRUG

Standard therapy for CMV prophylaxis

Valganciclovir

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NYP-Weill Cornell

New York, New York, 10021, United States

RECRUITING

Columbia University/NYP Milstein Hospital

New York, New York, 10032, United States

RECRUITING

Related Publications (6)

  • Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.

    PMID: 37279999BACKGROUND

  • Chong PP, Teiber D, Prokesch BC, Arasaratnam RJ, Peltz M, Drazner MH, Garg S. Letermovir successfully used for secondary prophylaxis in a heart transplant recipient with ganciclovir-resistant cytomegalovirus syndrome (UL97 mutation). Transpl Infect Dis. 2018 Oct;20(5):e12965. doi: 10.1111/tid.12965. Epub 2018 Jul 20.

    PMID: 29989279BACKGROUND

  • Saullo JL, Miller RA. Cytomegalovirus Therapy: Role of Letermovir in Prophylaxis and Treatment in Transplant Recipients. Annu Rev Med. 2023 Jan 27;74:89-105. doi: 10.1146/annurev-med-042921-124739. Epub 2022 Nov 4.

    PMID: 36332639BACKGROUND

  • Potena L, Solidoro P, Patrucco F, Borgese L. Treatment and prevention of cytomegalovirus infection in heart and lung transplantation: an update. Expert Opin Pharmacother. 2016 Aug;17(12):1611-22. doi: 10.1080/14656566.2016.1199684. Epub 2016 Jun 30.

    PMID: 27340928BACKGROUND

  • Saullo JL, Baker AW, Snyder LD, Reynolds JM, Zaffiri L, Eichenberger EM, Ferrari A, Steinbrink JM, Maziarz EK, Bacchus M, Berry H, Kakoullis SA, Wolfe CR. Cytomegalovirus prevention in thoracic organ transplantation: A single-center evaluation of letermovir prophylaxis. J Heart Lung Transplant. 2022 Apr;41(4):508-515. doi: 10.1016/j.healun.2021.12.005. Epub 2021 Dec 22.

    PMID: 35031206BACKGROUND

  • Rahman A, Lee C, Rahman S, Baranowska J, Moeller CM, Valledor AF, Rubenstein G, Oren D, Alnatour AT, Labarre B, Taek K, Bae D, Raikhelkar J, Lotan D, Defilippis EM, Yunis AA, Fried J, Latif F, Yuzefpolskaya M, Colombo PC, Lin E, Majure DT, Clerkin KJ, Choe J, Sayer G, Uriel N. Efficacy of Letermovir for Cytomegalovirus Prophylaxis in Heart Transplant Recipients with Moderate to High-Risk CMV Serostatus. J Card Fail. 2025 Jun 23:S1071-9164(25)00284-2. doi: 10.1016/j.cardfail.2025.05.017. Online ahead of print.

    PMID: 40562091BACKGROUND

MeSH Terms

Conditions

Rejection, Psychology

Interventions

letermovirValganciclovir

Condition Hierarchy (Ancestors)

Social BehaviorBehavior

Intervention Hierarchy (Ancestors)

GanciclovirAcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Central Study Contacts

Afsana Rahman, MD

CONTACT

2123054600ar3262@cumc.columbia.edu

Adel T Alnatour, BS

CONTACT

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

July 9, 2025

First Posted

July 23, 2025

Study Start

September 12, 2025

Primary Completion (Estimated)

January 17, 2028

Study Completion (Estimated)

January 17, 2029

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)