CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 570 enrolled
Drug / intervention
Letermovir +1 moredrug
Likely dose
Letermovir 240 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02137772
NCT02137772Phase 3Completed
CompareCT.gov

A Phase III Randomized, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-8228 (Letermovir) for the Prevention of Clinically Significant Human Cytomegalovirus (CMV) Infection in Adult, CMV-Seropositive Allogeneic Hematopoietic Stem Cell Transplant Recipients

Merck Sharp & Dohme LLC·interventional·Posted May 14, 2014·Updated Sep 11, 2019

In Brief

A Phase 3 clinical trial evaluating Letermovir and Placebo for Prevention of CMV Infection or Disease. Completed, enrolled 570 participants.

Detailed Summary

The study evaluated the efficacy and safety of letermovir (MK-8228) for the prevention of clinically-significant CMV infection in adult, CMV-seropositive recipients of allogeneic hematopoietic stem cell transplant (HSCT). The hypothesis being tested was that MK-8228 is superior to placebo in the prevention of clinically-significant CMV infection through Week 24 post-transplant.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention of CMV Infection or Disease
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMay 14, 2014
Enrollment StartJun 6, 2014
Primary CompletionAug 8, 2016
Study CompletionNov 21, 2016
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 12.1 years ago

Interventions

Letermovirdrug

Letermovir 240 mg / 480 mg tablets, or 240 mg / 480 mg intravenous solution in 250 mL to be infused over 60 minutes.

Placebodrug

Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.