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August 25, 2014
07:46 EDTRGDORegado terminates enrollment in REGULATE-PCI Phase 3 trial
Regado Biosciences announced the permanent termination of enrollment in its REGULATE-PCI phase 3 trial for its lead program, Revolixys Kit. The decision was made based on a recommendation from the trial’s Data and Safety Monitoring Board following their analysis of the data from the first approximately 3250 patients enrolled in what was intended to be a 13,200-patient trial comparing the safety and efficacy of Revolixys Kit with bivalirudin. The company said, “The DSMB indicated that the level of serious allergic adverse events associated with Revolixys was of a frequency and severity such that they recommended that we do not enroll any further patients in the REGULATE-PCI trial. We will now undertake a complete review of the unblinded database from REGULATE-PCI, which we expect will take several months to complete."
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