Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
Recruiting
Phase 2
Phase 3
Interventional Study
CMV Viremia
Heart Transplant Infection
Heart Transplant Failure and Rejection
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 150 (estimated)
- Sponsor
- Columbia University · Other
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About This Trial
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 Locations
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Eligibility Criteria
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.