Status:
RECRUITING
Cytomegalovirus Prophylaxis With Letermovir in Heart Transplant Recipients
Lead Sponsor:
University Medical Centre Ljubljana
Conditions:
CMV Viremia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
This protocol represents a Phase II pilot prospective non-randomized single arm open-label study design. We aim to enroll 30 patients after heart transplantation (Study Group), who will meet all of th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 interventional clinical trial
- know hypersensitivity to letermovir
- known hypersensitivity to valgancyclovir
- known hematological disorders (apart from anemia)
Key Trial Info
Start Date :
May 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05432778
Start Date
May 1 2023
End Date
August 1 2026
Last Update
November 9 2023
Active Locations (1)
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1
University Medical Center Ljubljana
Ljubljana, Slovenia, 1000