Phase 3
Completed N=120
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)
Source: ClinicalTrials.gov NCT05763823 ↗Enrolled (actual)
120
Serious AEs
58.3%
Results posted
Mar 2025
Primary outcomePrimary: Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant — 32 Percentage of Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant |
32 | — |
| SECONDARY Percentage of Participants Who Experienced an Adverse Event (AE) |
99.2 | — |
| SECONDARY Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event |
— | — |
| SECONDARY Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant |
7.1 | — |
| SECONDARY Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant |
7.1 | — |
| SECONDARY Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant |
32.7 | — |
| SECONDARY Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant |
6.1 | — |
| SECONDARY Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant |
11.2 | — |
| SECONDARY Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant |
5.1 | — |
| SECONDARY Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant |
6.1 | — |
Eligibility Criteria
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 randomization, or for hepatitis C virus antibody (HCV-Ab) with detectable HCV ribonucleic acid (RNA), or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
- Has active solid tumor malignancies except localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas).
- Has received any prohibited medications within 2 days prior to initiation of treatment with Letermovir.
- Is anticipated to be treated with Traditional Chinese Medicine or herbal medicine during the study treatment period and for 14 days after study medication.
Data sourced from ClinicalTrials.gov (NCT05763823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.