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Amgen Presents Data From First Nplate(R) Study in Children With Chronic ITP
Date:12/7/2009

those patients treated with Nplate or placebo with most adverse events being mild to moderate in severity. Most frequent adverse events in patients taking Nplate or placebo were headache (35 percent vs. 40 percent, respectively), epistaxis (35 percent vs. 20 percent, respectively), cough (12 percent vs. 40 percent, respectively) and vomiting (12 percent vs. 40 percent, respectively).

Efficacy results showed that Nplate was effective in treating thrombocytopenia compared to placebo, with 88 percent of the 17 patients receiving Nplate achieving both efficacy endpoints during treatment (number of patients achieving a platelet count of over 50,000 platelets per microliter for two consecutive weeks during the treatment period and/or achieving an increase in the platelet count of 20,000 platelets per microliter above baseline for two consecutive weeks). Other observations included a decrease in rescue medication use, and numerically lower duration-adjusted bleeding adverse event rates with Nplate treatment as compared with placebo. None of the placebo-treated patients (n=5) achieved either efficacy endpoints.

Study Design

This Phase 1/2, 12-week treatment period evaluated the safety and efficacy of Nplate in the treatment of thrombocytopenia in children with chronic ITP (n=22). The study involved children with ITP aged 12 months to less than 18 years old with persistent severe thrombocytopenia for at least six months. The median age of study participants was 9.5 years. Nplate was administered subcutaneously at 1 mcg/kg once-weekly and doses were adjusted to a maximum dose of 10 mcg/kg weekly.

Results from Ongoing, Long-Term Extension Efficacy and Safety Study (Abstract #681)

Results from an ongoing, long-term extension study in adults that were also presented at the meeting showed that Nplate maintained platelet counts within a range of 50,000 to 200,000 platelets per microliter in the majority of adu
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SOURCE Amgen
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