NCT02927067

A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 553 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cytomegalovirus (CMV)

Interventions

Type	Name	Description
DRUG	Maribavir	Participants will receive 400 mg of maribavir BID orally.
DRUG	Valganciclovir	Participants will receive valganciclovir tablets orally.
OTHER	Placebo	Participants will receive placebo tablets matched to either maribavir or valganciclovir.

Timeline

• Start date: 2017-04-14
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2016-10-06
• Last updated: 2023-03-03
• Results posted: 2023-03-03

Locations

129 sites across 23 countries: United States, Australia, 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

Regulatory

• FDA-regulated drug study