WebMaribavir is an oral benzimidazole riboside with potent in vitro activity against cytomegalovirus (CMV), including some CMV strains resistant to ganciclovir. In a randomized, double-blind, multicenter trial, the efficacy and safety of prophylactic oral maribavir (100 mg twice daily) for prevention o … WebDec 4, 2024 · The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing eight weeks of treatment with either maribavir or investigator...
Takeda Says Phase 3 SOLSTICE Trial Met Its Primary Endpoint
WebFeb 12, 2024 · “We are pleased that the SOLSTICE trial, which compared maribavir to available antiviral treatments for transplant patients with refractory/resistant … WebJun 7, 2024 · The TAK-620-303 (SOLSTICE) trial (NCT02931539) is a multicenter, randomized, open-label, active-controlled trial comparing treatment with either maribavir or investigator assigned treatment, IAT ... identify the standardized test statistic z
Drug Resistance Mutations and Associated Phenotypes Detected …
WebOct 7, 2024 · The New Drug Application (NDA) for maribavir is currently under Priority Review by the FDA. The FDA will consider the vote as part of its review of the NDA and is not bound by the AMDAC’s... WebMay 21, 2024 · The NDA is based on Phase III data from the SOLSTICE trial that showed Maribavir demonstrated superiority compared to conventional antiviral therapies in this patient population. The study's primary endpoint was defined as the proportion of patients who achieved confirmed CMV viremia clearance compared to IAT at the end of eight weeks. Webfor the SOLSTICE Trial Investigators. Maribavir for Refractory Cytomegalovirus Infections With or Without Resistance Post-Transplant: Results from a Phase 3 Randomized Clinical Trial. CID 2024 Sep 10;75(4):690-701. DocuSign Envelope ID: 87C540AF-E7E9-4D0B-ACE5-8F6649D0ACD7 identify the stakeholders in ethics