Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorColumbia University
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Letermovir
DrugCMV prophylaxis
Valganciclovir
DrugStandard therapy for CMV prophylaxis
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: LetermovirExperimental treatment 1 intervention
Group B: ValganciclovirActive comparator 1 intervention
Group C: No treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Occurrence of leukopenia
Number of patients with leukopenia (white blood cell count \<3000 cells µL)
Time frame
During the duration of CMV prophylaxis (6 months for moderate risk and 12 months for high risk from start of therapy)2
Occurrence of neutropenia
Number of patients with neutropenia (absolute neutrophil count \<1500 cells/µL)
Time frame
During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk from start of therapy)Secondary outcomes
1
Number of patients with any detectable CMV viremia after initiation of CMV prophylaxis
Number of patients with any positive CMV viral load detected by polymerase chain reaction (PCR)
Time frame
6 months after initiation of CMV prophylaxis2
Number of patients with any detectable CMV viremia while on CMV prophylaxis
Number of patients with any positive CMV viral load detected by PCR.
Time frame
During the duration of CMV prophylaxis (Up to 6 months for moderate risk and up to 12 months for high risk patients)3
Number of patients with any detectable CMV viremia after completing CMV prophylaxis
Number of patients with any positive CMV viral load detected by PCR.
Time frame
Within 6 months after completing CMV prophylaxisOther outcomes
1
Percent of CD4 and CD8 T cells that respond to CMV antigen
Exploratory: looking at T cell unity against CMV. Assessing the predictive attributes of a positive test on the chance of future CMV viremia or disease.
Time frame
6 months to 1 year after initiating CMV prophylaxis2
Viral load of the torque teno virus (TTV)
Exploratory: TTV activity will be measured by the TTV assay. This will be used to assess the immunogenicity of heart transplant patients that are identified as being at increased risk of infection or rejection.
Time frame
6 months to 1 year after initiating CMV prophylaxisSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Cornell University
Collaborator
Source ClinicalTrials.gov