NCT05763823CompletedPhase 3
A Phase 3, Open Label, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) for the Prevention of Clinically Significant Cytomegalovirus (CMV) Infection in Chinese Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients
Merck Sharp & Dohme LLC21 sites in 1 country120 target enrollmentStarted: March 24, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 120
- Locations
- 21
- Primary Endpoint
- Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Letermovir (Drug)
Outcomes
Primary Outcomes
Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant
Time Frame: Up to Week 24 post-transplant (approximately 6 months)
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.
Secondary Outcomes
- Percentage of Participants Who Experienced an Adverse Event (AE)(Up to 16 weeks)
- Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event(Up to 14 weeks)
- Percentage of Participants With Clinically Significant CMV Infection up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
- Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
- Percentage of Participants With Preemptive Therapy for CMV Viremia up to Week 24 Post-Transplant(Up to 24 weeks post-transplant (approximately 6 months))
- Percentage of Participants With CMV End-organ Disease up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
- Percentage of Participants With CMV End-organ Disease up to Week 24 Post-Transplant(Up to 24 weeks post-transplant (approximately 6 months))
- Percentage of Participants With All-Cause Mortality up to Week 14 Post-Transplant(Up to 14 weeks post-transplant (99 days))
- Percentage of Participants With All-cause Mortality up to Week 24 Post-Transplant(Up to 24 weeks post-transplant (approximately 6 months))
Investigators
Study Sites (21)
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