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Cytomegalovirus Prophylaxis with Letermovir in Heart Transplant Recipients: A Non-randomized Cohort Pilot Study
EU CTIS ID: 2024-517354-98-00
What this study is testing
The primary objective of the study is to investigate the efficacy of letermovir-based CMV prophylaxis in patients after heart transplantation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- •heart transplant recipient (new)
- •moderate (D+/R+ and D-/R+) or high (D+/R-) risk CMV serostatus
- •signed informed consent for participation in the study
- • age ≥ 18 years
- •not enrolled in competing clinical trials
You likely can't join if
- •short-term mechanical circulatory support prior HTX
- •known hypersensitivity to letermovir
- •known hypersensitivity to valgancyclovir
- •known hematological disorders (apart from anemia)
- •history of malignancy (< 5 years; except adequately treated basal or squamous cell skin cancer or in situ cervical cancer) or under evaluation for active or suspected malignancy
- •advanced kindey disease (CrCL < 10 ml/min) at enrollment
See the full eligibility criteria
- •heart transplant recipient (new)
- •moderate (D+/R+ and D-/R+) or high (D+/R-) risk CMV serostatus
- •signed informed consent for participation in the study
- • age ≥ 18 years
- •not enrolled in competing clinical trials
- •short-term mechanical circulatory support prior HTX
- •known hypersensitivity to letermovir
- •known hypersensitivity to valgancyclovir
- •known hematological disorders (apart from anemia)
- •history of malignancy (< 5 years; except adequately treated basal or squamous cell skin cancer or in situ cervical cancer) or under evaluation for active or suspected malignancy
- •advanced kindey disease (CrCL < 10 ml/min) at enrollment
- •advanced liver disease (Child Pugh Class C)
- •combined moderate kidney (CrCL < 50 ml/min) and liver (Child Pugh Class B) insufficiency at screening
- •concomitant administration with pimozide
- •concomitant administration with ergot alkaloids
- •concomitant administration with St. John’s wort (Hypericum perforatum)
- •multi-organ transplantation
- •concomitant administration of cyclosporine
- •concomitant use of dabigatran, atorvastatin, simvastatin, rosuvastatin or pitavastatin is contraindicated
- •known hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- •combined hepatic and renal impairment
- •HIV infection
- •Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or put the participant at undue risk, as judged by the investigator, such that it is not in the best interest of the participant to participate in this study
- •Has previously participated in this study or any other study involving letermovir.
- •Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
- •ongoing CMV infection/disease
- •D-/R- CMV serostatus
- •heart re-transplantation
- •need for intensified immunosuppression protocol (>20% cytolytic alloantibodies prior transplant or perioperative (within 7 days after HTX) allograft rejection > 1R)
- •immunoinduction with ATG
- •pregnancy
- •active participation in another interventional clinical trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.