12:00 AM
Nov 12, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Rapiacta: Phase III discontinued

BioCryst discontinued the double-blind, international Phase III BCX1812-301 trial of peramivir for futility based on a pre-planned interim analysis of 119 patients not treated with neuraminidase inhibitors as SOC. According to BioCryst, the interim analysis showed only a "small difference" on the primary endpoint of time to clinical resolution between the peramivir plus SOC and the placebo plus SOC arms. BioCryst said the goal of the interim analysis was to recalculate the sample size required for the primary endpoint analysis and make adjustments as necessary. The company said that the recalculated sample size exceeded the futility boundary of 320 patients. The trial enrolled 405 of a planned 600 patients who were hospitalized for serious influenza infection to receive SOC plus once-daily 600 mg IV peramivir or placebo for 5 days.


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