NCT03930615

Extension of Letermovir (LET) From Day 100 to Day 200 Post-transplant for the Prevention of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Participants (MK-8228-040)

A Phase 3 Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of Letermovir (LET) Prophylaxis When Extended From 100 Days to 200 Days Post-transplant in Cytomegalovirus (CMV) Seropositive Recipients (R+) of an Allogenic Hematopoietic Stem Cell Transplant (HSCT)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the safety and efficacy of letermovir (LET) versus placebo when cytomegalovirus (CMV) prophylaxis was extended from 100 days to 200 days post-transplant in CMV seropositive participants who received an allogenic hematopoietic stem cell transplant (HSCT). It was hypothesized that LET is superior to placebo in the prevention of clinically-significant CMV infection when LET prophylaxis is extended from 100 to 200 days.

Conditions

• Cytomegalovirus Infection

Interventions

Type	Name	Description
DRUG	Letermovir	LET tablet or intravenous infusion at a total daily dose of 240 mg (when given with cyclosporin A) or 480 mg (when given alone).
DRUG	Placebo	Placebo was administered as tablets matched to LET or as inactive (saline or dextrose) intravenous infusion.

Timeline

• Start date: 2019-06-21
• Primary completion: 2021-10-27
• Completion: 2022-03-16
• First posted: 2019-04-29
• Last updated: 2024-08-22
• Results posted: 2022-11-01

Locations

32 sites across 6 countries: United States, France, Germany, Italy, Japan, United Kingdom

Regulatory

• FDA-regulated drug study