BioCentury
ARTICLE | Clinical News

Rhucin: Completed Phase III enrollment

July 9, 2012 7:00 AM UTC

Pharming completed enrollment of 75 patients in the double-blind, placebo-controlled, U.S. Phase III Study 1310 trial evaluating IV Rhucin. Patients weighing <84 kg will receive 50 units/kg of Rhucin and those weighing >=84 kg will receive 4,200 units of Rhucin. The trial will continue until either all patients have received treatment for a repeat HAE attack or achieved a 90-day attack-free period. Pharming said 53 patients have experienced either event. The trial has an SPA from FDA. Last month, the company said an undisclosed "internal oversight" could delay the report of top-line data from Study 1310 by 3 months to 4Q12 from 3Q12 (see BioCentury, July 2). ...