Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05763823 | 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) | PHASE3 | COMPLETED | 120 | — | — | Mar 24, 2023 | Apr 18, 2024 | Mar 25, 2025 | 21 | China |
| NCT04129398 | MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) | PHASE3 | COMPLETED | 22 | — | — | Dec 27, 2019 | Oct 6, 2022 | Aug 21, 2024 | 4 | Japan |
| NCT03930615 | Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040) | PHASE3 | COMPLETED | 220 | — | — | Jun 21, 2019 | Mar 16, 2022 | Aug 22, 2024 | 32 | United States, France +4 |
Clinically significant CMV infection was defined as either one of the following: 1) initiation of anti-CMV pre-emptive therapy based on documented CMV viremia and the clinical condition of the participant or 2) onset of CMV end-organ disease. The percentage of participants with clinically significant CMV infection up to week 24 post-transplant is reported.
Percentage of participants with one or more adverse events (AEs)
Percentage of participants who discontinued from study drug due to an AE
Clinically significant CMV infection is either the onset of probable or proven CMV end-organ disease or initiation of anti-CMV preemptive therapy (PET) with approved anti-CMV agents (ganciclovir, valganciclovir, foscarnet, and/or cidofovir) based on documented CMV viremia and the clinical condition of the participant. Missing values were handled by the observed failure (OF) approach where failure was defined as all participants who develop clinically significant CMV infection or discontinue prematurely from the study with CMV viremia from week 14 (\~100 days) through week 28 post-transplant. It was hypothesized that LET is superior to placebo in the prevention of clinically significant CMV infection when LET prophylaxis is extended from 100 to 200 days.
| Arm | Type | Description |
|---|---|---|
| Letermovir | EXPERIMENTAL | Chinese HSCT recipients will receive 240 mg of Letermovir \[for participants on Cyclosporin A (CsA)\] or 480 mg of Letermovir (for participants not on CsA) either orally or IV once daily through week 14 (\~100 days) post-transplant. |
| Placebo | PLACEBO_COMPARATOR | Participants who received HSCT transplant and 100 days of LET prophylaxis were randomized to an additional 100 days of placebo treatment. |
| Name | Type | Description |
|---|---|---|
| Letermovir | DRUG | Daily 240 mg or 480 mg oral tablets or IV dose |
| Letermovir tablet | DRUG | A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks |
| Letermovir IV | DRUG | 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 |
| Placebo | DRUG | Placebo was administered as tablets matched to LET or as inactive (saline or dextrose) intravenous infusion. |
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 \[IgG\] se...