CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Letermovirdrug
Likely dose
Letermovir 480mgfrom 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/NCT03728426
NCT03728426Phase 2Completed
CompareCT.gov

A Phase 2 Study of Letermovir Treatment for Patients Experiencing Refractory or Resistant Cytomegalovirus Infection or Disease With Concurrent Organ Dysfunction

Amy C. Sherman, MD·interventional·Posted Nov 2, 2018·Updated Mar 8, 2023

In Brief

A Phase 2 clinical trial evaluating Letermovir for Cytomegalovirus Infections. Completed, enrolled 10 participants across 4 sites.

Detailed Summary

The trial will evaluate the safety and efficacy of letermovir antiviral treatment of active cytomegalovirus infection or cytomegalovirus disease in patients with infections that are refractory or resistant to available treatments or who are experiencing organ dysfunction that makes unsafe the use of available antiviral treatments.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Infections
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2, 2018
Enrollment StartJan 11, 2019
Primary CompletionMar 28, 2022
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 7.7 years ago

Interventions

Letermovirdrug

Patients will receive intravenous or oral letermovir at a dose of 480mg/day. Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment. For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day.