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Clinical Trials/NCT05763823
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
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

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (21)

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