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New treatment option for CMV Viremia
Official title Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients
ClinicalTrials.gov ID: NCT05432778
What this study is testing
What is Letermovir Pill?
Letermovir Pill is an investigational medicine, given as a monthly pill taken by mouth, being studied as a potential treatment for cmv viremia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- CMV infection is the most prevalent infection after heart transplantation (HTX), occurring in up to 40-60% of the recipients. It most frequently occurs within the first 6 months after transplantation and commonly presents as an asymptomatic viral replication.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
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
You likely can't join if
- short-term mechanical circulatory support prior HTX
- ongoing CMV infection/disease
- D-/R- CMV serostatus
- heart re-transplantation
- need for intensified immunosuppression protocol
- \>20% cytolytic alloantibodies prior transplant
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
- short-term mechanical circulatory support prior HTX
- ongoing CMV infection/disease
- D-/R- CMV serostatus
- heart re-transplantation
- need for intensified immunosuppression protocol
- \>20% cytolytic alloantibodies prior transplant
- perioperative (within 7 days after HTX) allograft rejection \> 1R
- immunoinduction with ATG
- pregnancy
- active participation in another treatment clinical trial
- know hypersensitivity to letermovir
- known hypersensitivity to valgancyclovir
- known hematological disorders (apart from anemia)
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
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, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.