Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT07079735
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • CMV Viremia
  • Heart Transplant Failure and Rejection
  • Heart Transplant Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Letermovir — DRUG
    CMV prophylaxis
  • Valganciclovir — DRUG
    Standard therapy for CMV prophylaxis

Study Details

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.

Key Dates

Start date
Sep 12, 2025
Status verified
Sep 2025
Primary completion
Jan 17, 2028
Completion
Jan 17, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

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) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia University/NYP Milstein HospitalNew YorkNew York10032
Afsana Rahman, MD
[email protected]
2123054600
Adel T Alnatour, BS
Afsana Rahman, MD (PRINCIPAL_INVESTIGATOR)
NYP-Weill CornellNew YorkNew York10021
David Majure, MD
[email protected]
6469629062
Adel T Alnatour, BS
David Majure, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University/NYP Milstein Hospital· New York, NYNYP-Weill Cornell· New York, NY

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