ARTICLE | Clinical News

Promacta: Additional Phase III data

February 13, 2012 8:00 AM UTC

Additional data from the double-blind, international Phase III ENABLE 1 trial in 682 evaluable patients showed that 23% of patients receiving Promacta achieved an SVR 24 weeks after the end of treatment, the primary endpoint, vs. 14% for placebo (p=0.0064). The trial enrolled chronic HCV patients with baseline platelets <75,000/µL to receive open-label once-daily 25 mg Promacta with dose-escalations every 2 weeks to 100 mg until platelets were >=90,000/µL. Patients achieving a platelet count of >=90,000/µL were randomized to receive peginterferon alfa-2a and ribavirin in combination with Promacta or placebo for 24 (HCV genotype 2/3 infected-patients) or 48 weeks (HCV genotype 2/3 infected-patients). Data were presented at the American Association for the Study of Liver Diseases meeting in San Francisco last November. ...