In May, Bayer AG discontinued a Phase 2/3 trial for BAY 86-6150, its investigational recombinant factor VIIa (rFVIIa) product for the treatment of patients with hemophilia A or hemophilia B and inhibitors. The trial, designed to evaluate the safety and efficacy of BAY 86-6150 in people with inhibitors, was stopped because of the presence of neutralizing inhibitors in subjects. The study, “TReatment with Unique Recombinant rFVIIa STudy (TRUST)” was an open-label, multicenter clinical trial.
"Patient safety is our primary concern when designing clinical trials and evaluating BAY 86-6150,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “Due to safety concerns, we are discontinuing the BAY 86-6150 trial as a precautionary measure.”
Source: foxbusiness.com, May 3, 2013; Bayer press release dated May 3, 2013