NCT04129398

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

A Phase 3, Open-Label, Single-Arm Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of MK-8228 (Letermovir) for the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, efficacy and pharmacokinetics (PK) of Letermovir (LET) administered as prevention of cytomegalovirus (CMV) infection and disease in adult Japanese kidney transplant recipients.

Conditions

• Cytomegalovirus Infection
• Cytomegalovirus Disease

Interventions

Type	Name	Description
DRUG	Letermovir tablet	A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks
DRUG	Letermovir IV	IV solution of 240 mg (one vial) or 480 mg (2 vials) letermovir in 250 mL infused over 60 minutes, once daily for 28 weeks

Timeline

• Start date: 2019-12-27
• Primary completion: 2022-10-06
• Completion: 2022-10-06
• First posted: 2019-10-16
• Last updated: 2024-08-21
• Results posted: 2024-04-01

Locations

4 sites across 1 country: Japan