CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 352 enrolled
Drug / intervention
Maribavir +4 moredrug
Likely dose
Maribavir 400 milligramsfrom 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/NCT02931539
NCT02931539Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir

Shire·interventional·Posted Oct 13, 2016·Updated Nov 3, 2021

In Brief

A Phase 3 clinical trial evaluating Maribavir, Ganciclovir, and 3 other interventions for Cytomegalovirus (CMV). Completed, enrolled 352 participants across 134 sites in 14 countries.

Detailed Summary

The purpose of this study is to compare the efficacy of maribavir to investigator-assigned anti-Cytomegalovirus (CMV) therapy in CMV viremia clearance in transplant recipients who are refractory or resistant to prior anti-CMV treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus (CMV)
CountriesAustralia, Austria, Belgium, Canada, Croatia, Denmark, France, Germany, Italy, Singapore, Spain, Switzerland, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 13, 2016
Enrollment StartDec 22, 2016
Primary CompletionAug 17, 2020
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.7 years ago

Interventions

Maribavirdrug

Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.

Ganciclovirdrug

Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Valganciclovirdrug

Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Foscarnetdrug

Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.

Cidofovirdrug

Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.