A Study of Letermovir (MK-8228) to Evaluate Efficacy and Safety for Prevention of CMV Infection in Chinese Hematopoietic Stem Cell Transplant Recipients (MK-8228-045)

• Status: Not yet recruiting
• Trial end date: 2025-05-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the efficacy and safety of once-a-day orally or IV dose of Letermovir (MK-8228) in Chinese adult Hematopoietic Stem Cell Transplant (HSCT) recipients for the prevention of clinically significant Cytomegalovirus (CMV) Infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme LLC
• Treatments: Letermovir

Criteria

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

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.