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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) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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)

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

NCT05763823•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+2 more criteria

Locations (21)

Anhui Provincial Hospital ( Site 0024)

Hefei, Anhui, China

Peking University First Hospital ( Site 0009)

Beijing, Beijing Municipality, China

Peking University People's Hospital-Hematology ( Site 0033)

Beijing, Beijing Municipality, China

The Second Affiliated Hospital of Third Military Medical University-Oncology Department ( Site 0002)

Chongqing, Chongqing Municipality, China

Southwest Hospital of Third Military Medical University ( Site 0005)

Chongqing, Chongqing Municipality, China

The Second Affiliated Hospital Chongqing Medical University ( Site 0013)

Chongqing, Chongqing Municipality, China

Guangzhou First People's Hospital-Hematology Department ( Site 0001)

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital ( Site 0003)

Guangzhou, Guangdong, China

Shenzhen Second People's Hospital-Hematology Department ( Site 0006)

Shenzhen, Guangdong, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0028)

Wuhan, Hubei, China

Key Dates

Start Date

March 24, 2023

Primary Completion Date

April 18, 2024

Completion Date

April 18, 2024

Last Updated

March 25, 2025

Enrollment

120

ACTUAL participants

Conditions

Cytomegalovirus Infection

Interventions

Letermovir

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 25, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

Is Valacyclovir Non-inferior to Valganciclovir as CMV and EBV Prophylaxis in Kidney Transplant Recipients? A Single-Center Prospective Randomized Pilot Study

R-MVST Cells for Treatment of Viral Infections in Children and Young Adults

Letermovir for Secondary Prophylaxis in Solid Organ Transplant Recipients

A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System®

A Study of Safety and Immune Response to Different Doses of a Cytomegalovirus Vaccine in Healthy Adults

Clinical and Genetic Analysis of Enlarged Vestibular Aqueducts