CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 553 enrolled
Drug / intervention
Maribavir +2 moredrug
Likely dose
Maribavir 400 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/NCT02927067
NCT02927067Phase 3Completed
CompareCT.gov

A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients

Shire·interventional·Posted Oct 6, 2016·Updated Mar 3, 2023

In Brief

A Phase 3 clinical trial evaluating Maribavir, Valganciclovir, and 1 other intervention for Cytomegalovirus (CMV). Completed, enrolled 553 participants across 129 sites in 23 countries.

Detailed Summary

This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after treatment with marivabir or valganciclovir. Participants will take 2 tablets of marivabir or valganciclovir and 2 tablets of placebo twice a day for 8 weeks. A placebo will look like marivabir or valganciclovir but will not have any medicine in it. After treatment, each participant will be followed up for up to 12 weeks. Participants will visit their study clinic up to 18 times during the study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus (CMV)
CountriesAustralia, Austria, Belgium, Canada, China, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, New Zealand, Poland, Russia, Singapore, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
CollaboratorsTakeda Development Center Americas, Inc.

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedOct 6, 2016
Enrollment StartApr 14, 2017
Primary CompletionJul 1, 2022
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 9.7 years ago

Interventions

Maribavirdrug

Participants will receive 400 mg of maribavir BID orally.

Valganciclovirdrug

Participants will receive valganciclovir tablets orally.

Placeboother

Participants will receive placebo tablets matched to either maribavir or valganciclovir.