Clinical Trials Resource Center

Platelet Disorders

December 12, 2005

GlaxoSmithKline and Ligand have reported positive results of a phase II trial of their investigational small molecule thrombopoietic eltrombopag (SB-497115), for the treatment of idiopathic thrombocytopenia purpura (ITP). Results indicated that the two highest doses of the drug significantly increased the portion of patients with platelet counts above 50,000 at 6 weeks, compare to placebo (66% for 50 mg/day, 87% for 75 mg/day, vs. 13% for placebo; p=<0.001). Results were not significant for the lowest trial dose (p=0.98). Incidence of overall adverse events was comparable between drug and placebo cohorts, and serious adverse events occurred in a lower portion of subjects receiving eltrombopag (7.7%) than placebo (15%). This randomized, double-blind, placebo-controlled dose-ranging study enrolled 95 adult patients with chronic refractory ITP, who received daily administration of one of 3 doses of the drug (30 mg, 50 mg or 75 mg) or placebo for 6 weeks.

August 29, 2005

Baxter Healthcare reported positive results from a multi trials investigating Advate, a recombinant antihemophilic factor for the treatment of hemophilia A. The first results were from a preliminary assessment of a prospective international, multi-center study enrolling 53 pediatric subjects less than six years of age who were previously treated with factor VIII. Results demonstrated that no patients discontinued therapy as a result of an adverse event and no incidence of factor VIII antibodies were reported in this study. The second were of preliminary results of a multi- center, prospective, open-label, uncontrolled study designed to test the efficacy, safety and immunogenicity on 57 hemophilia A subjects undergoing surgery or other invasive procedures. An interim assessment of the first 44 procedures performed demonstrated an efficacy rating of excellent/good in 97.7% of surgeries. The company presented the data at the 20th Congress of the International Society on Thrombosis and Haemostasis held in Sydney, Australia.

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