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