Letermovir for R+ Study
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
The purpose of this clinical trial is to find out whether a medication, called letermovir, can help prevent a virus called cytomegalovirus (CMV) in participants who receive a kidney or liver transplant and who have already been exposed the CMV.
Participants will take letermovir for 84 days.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults who are at moderate risk for CMV after transplant (CMV IGG+, including D+/R+ or D-/R+)
Adults who received a kidney transplant, liver transplant, or any combination thereof
Disqualifiers
Known contraindication to letermovir or its excipients
Current participation in another CMV related study
Unwilling or unable to participate in the study protocol
Trial design
Design model
Single group
Treatments tested in this trial
Letermovir
Drug1 tablet by mouth, once daily, for 84 days
Treatment groups
146 Participants
are divided into 1 treatment groupGroup A: Receive letermovirExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of letermovir as a prophylaxis of CMV
Efficacy will be measured through comparative rates of antiviral failure. Failure will be defined as withdrawal due to intolerance or breakthrough viral replication to a viral load \>1000 IU/mL.
Time frame
84 daysSecondary outcomes
1
Percentage of participants who develop cytomegalovirus-specific cell-mediated immunity
To be measured using the Eurofins-Viracor CMV inSIGHT™ T Cell Immunity testing. The test measures the strength of T cell responses to Cytomegalovirus (CMV) specific antigens.
Time frame
84 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: