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ViroPharma Announces Publication of Cinryze™ (C1 Esterase Inhibitor [Human]) Phase 3 Trial Results in Hereditary Angioedema (HAE) in the New England Journal of Medicine
Date:8/5/2010

8.66 versus 15.4 +/- 8.41 injections, p<0.001) and the total number of days of swelling (10.1 +/- 10.73 versus 29.6 +/- 16.9 days; p<0.001).

Cinryze Acute Treatment Study

According to the authors, subjects experiencing attacks of moderate or severe intensity involving the abdomen, face, or external genitalia were eligible for randomized treatment. Eligible subjects were then randomized to receive either Cinryze (1000 U) or saline by intravenous push over 10 minutes. After 60 minutes, a second injection of the same study drug was administered if the subject had not reported symptoms to be either "absent" or "better" at the site of the most severe symptoms which had been designated as the "defining site".  Symptom severity was assessed every 15 minutes starting from the initial injection and continuing until the subject reported "unequivocal relief," defined as three consecutive reports of improvement at the defining site. If four hours had elapsed without "unequivocal relief," trial assessments were discontinued and rescue therapy with open-label Cinryze was offered.  

The primary end point was the time from study drug administration until the onset of unequivocal relief of symptoms at the defining site. Secondary efficacy measures included percentage of subjects who had unequivocal relief within four hours following treatment; time to complete resolution of the attack; and effects of treatment on C1 inhibitor antigenic and functional levels and C4 levels.  Safety of Cinryze was also assessed.

Seventy-one eligible subjects were randomized into this study, 36 to Cinryze and 35 to placebo. After completion of study treatment, three subjects (one randomized to Cinryze and two randomized to placebo) were judged by an independent, blinded expert to have experienced episodes that were not true attacks of angio
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SOURCE ViroPharma Incorporated
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