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 U.S. Food and Drug Administration (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: USA
Trial
details: The purpose of this study is to determine if maribavir is safe and effective in treating transplant recipient patients with cytomegalovirus (CMV) infections that are refractory or resistant to treatment with ganciclovir, valganciclovir, foscarnet, or cidofovir. (NCT02931539)
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. Thestudy SHP620-303 is a randomized study comparing maribavir to investigator’s choice anti-CMV treatment among transplant patients with resistant and/or refractory CMV disease.
