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CompletedPhase 3

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)

Key facts

Who runs it
Merck Sharp & Dohme LLC
Where
China21 sites in 1 countryChoose a country to see its sites
Trial code
Status
Completed
Phase
Phase 3
People taking part
120 people enrolled
Started
24 Mar 2023
Ended
18 Apr 2024
Type of study
Interventional
Treatments tested
  • Letermovir
Record updated
25 March 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Received a previous allogeneic HSCT
  • Has a history of CMV end-organ disease within 6 months prior to randomization
  • 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 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
  • Has severe hepatic insufficiency
  • 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 active solid tumor malignancies except localized basal cell or squamous cell skin cancer or the condition under treatment (e.g., lymphomas)
  • 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 evidence of CMV viremia at any time from HSCT procedure until the time of randomization

Other criteria

  • The key inclusion and exclusion criteria include but are not limited to the following:

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The group in the trial

  • LetermovirTreatment being tested

    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.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Record updated
25 March 2025