A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus… (NCT05763823) | Clinical Trial Compass
CompletedPhase 3
A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of Cytomegalovirus Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)
China120 participantsStarted 2023-03-24
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of a once-a-day oral or intravenous (IV) dose of Letermovir (MK-8228) in Chinese adult hematopoietic stem cell transplant (HSCT) recipients for the prevention of clinically significant cytomegalovirus (CMV) infection.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The key inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
* Male/Female Chinese adult participant of an allogeneic Hematopoietic Stem Cell Transplant (HSCT).
* Has documented positive Cytomegalovirus (CMV) serostatus (CMV immunoglobulin G \[IgG\] seropositive) for recipient (R+) at the time of screening.
* Is receiving a first allogeneic HSCT.
* Is within 28 days post-HSCT at the time of randomization.
* Female participant is not a Woman of Child Bearing Potential (WOCBP) or is a WOBCP who agrees to use acceptable contraception during the treatment period and for ≥28 days after the last dose of study drug.
Exclusion Criteria:
* Received a previous allogeneic HSCT.
* Has a history of CMV end-organ disease within 6 months prior to randomization.
* Has evidence of CMV viremia at any time from HSCT procedure until the time of randomization.
* Has severe hepatic insufficiency.
* Is a) on renal replacement therapy (e.g., hemodialysis, peritoneal dialysis) OR b) has end stage renal impairment with a creatinine clearance \<=10 mL/min within 5 days prior to randomization.
* Has both moderate hepatic insufficiency AND moderate to severe renal insufficiency.
* Has an uncontrolled infection on the day of randomization.
* Has rapidly progressing disease that requires mechanical ventilation or is hemodynamically unstable.
* Has a documented positive result for a human immunodeficiency virus antibody (HIV-Ab) test at any time prior to ran…
What they're measuring
1
Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant
Timeframe: Up to Week 24 post-transplant (approximately 6 months)