At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 22 enrolled
Drug / intervention
Letermovir tablet +1 moredrug
Likely dose
Letermovir tablet 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Open-Label, Single-Arm Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MK-8228 (Letermovir) for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients
In Brief
A Phase 3 clinical trial evaluating Letermovir tablet and Letermovir IV for Cytomegalovirus Infection and Cytomegalovirus Disease. Completed, enrolled 22 participants across 4 sites.
Detailed Summary
This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infection, Cytomegalovirus Disease
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartDec 2019
Primary CompletionOct 2022
TodayJul 2026
First PostedOct 16, 2019
Enrollment StartDec 27, 2019
Primary CompletionOct 6, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.7 years ago
Interventions
Letermovir tabletdrug
A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks
Letermovir IVdrug
IV solution of 240 mg (one vial) or 480 mg (2 vials) letermovir in 250 mL infused over 60 minutes, once daily for 28 weeks