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)

NCT05763823 | Completed Phase 3 Results

• 2 other identifiers: 8228-045MK-8228-045
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 21

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.

Conditions

Cytomegalovirus Infection

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Clinically Significant Cytomegalovirus (CMV) Infection up to Week 24 Post-Transplant

  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.

  Up to Week 24 post-transplant (approximately 6 months)

Secondary Outcomes (9)

• 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)

Study Arms (1)

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.

Drug: Letermovir

Interventions

Letermovir DRUG

Daily 240 mg or 480 mg oral tablets or IV dose

Also known as: MK-8228

Letermovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (21)

Anhui Provincial Hospital ( Site 0024)

Hefei, Anhui, 230071, China

Location

Peking University First Hospital ( Site 0009)

Beijing, Beijing Municipality, 100034, China

Location

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

Beijing, Beijing Municipality, 100034, China

Location

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

Chongqing, Chongqing Municipality, 400037, China

Location

Southwest Hospital of Third Military Medical University ( Site 0005)

Chongqing, Chongqing Municipality, 400038, China

Location

The Second Affiliated Hospital Chongqing Medical University ( Site 0013)

Chongqing, Chongqing Municipality, 400072, China

Location

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

Guangzhou, Guangdong, 510180, China

Location

Southern Medical University Nanfang Hospital ( Site 0003)

Guangzhou, Guangdong, 510515, China

Location

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

Shenzhen, Guangdong, 518035, China

Location

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

Wuhan, Hubei, 430022, China

Location

Tongji Hospital Tongji Medical,Science & Technology ( Site 0032)

Wuhan, Hubei, 430030, China

Location

The First Affiliated Hospital of Soochow University-hematology department ( Site 0029)

Suzhou, Jiangsu, 215006, China

Location

The Affiliated Hospital of Xuzhou Medical College ( Site 0022)

Xuzhou, Jiangsu, 221006, China

Location

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 0021)

Nanchang, Jiangxi, 330209, China

Location

The First Hospital of Jilin University-Hematology ( Site 0023)

Changchun, Jilin, 130021, China

Location

The 2nd Affiliated Hospital of Dalian Medical University ( Site 0019)

Dalian, Liaoning, 116023, China

Location

Shanghai General Hospital ( Site 0018)

Shanghai, Shanghai Municipality, 200080, China

Location

West China Hospital, Sichuan University ( Site 0008)

Chengdu, Sichuan, 610041, China

Location

The General Hospital of Western Theater Command ( Site 0007)

Chengdu, Sichuan, 610083, China

Location

Institute of hematology&blood disease hospital-Hematology ( Site 0030)

Tianjin, Tianjin Municipality, 300020, China

Location

The First Affiliated Hospital, Zhejiang University ( Site 0025)

Hangzhou, Zhejiang, 310003, China

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Cytomegalovirus Infections

Interventions

letermovir

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2023
• First Posted: March 10, 2023
• Study Start: March 24, 2023
• Primary Completion: April 18, 2024
• Study Completion: April 18, 2024
• Last Updated: March 25, 2025
• Results First Posted: March 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (21)