Date: 2016-09-29
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Shire (UK - USA)
Product: maribavir
Action
mechanism: antiviral agent. Maribavir has shown activity against CMV strains resistant to other agents. The agent was originally being developed by ViroPharma, Incorporated, which Shire acquired in November 2013. The FDA and the European Commission have granted Orphan Drug Designation to maribavir for treatment of clinically significant cytomegalovirus viremia and disease in at-risk patients, and treatment of cytomegalovirus disease in patients with impaired cell mediated immunity, respectively.
Disease: cytomegalovirus infections
Therapeutic area: Infectious diseases
Country:
Trial
details: The purpose of this study is to compare the efficacy and safety of maribavir to valganciclovir for the treatment of cytomegalovirus (CMV) infection in asymptomatic hematopoietic stem cell transplant recipients. (NCT02927067)
Latest
news: * On September 29, 2016, a Phase 3 trial sponsored by Shire was published on the NIH website ClinicalTrials.gov for maribavir and is currently recruiting participants. The randomized double blind study SHP620-302 will compare maribavir to oral valganciclovir among patients with hematopoietic stem cell transplant and asymptomatic CMV infection.
