Idiopathic thrombocytopenic purpura (ITP)

Study Title: A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy (Amgen Protocol 20030105)

 

This study is designed to assess the efficacy and safety of an investigational treatment for adult thrombocytopenic subjects with ITP who have had a splenectomy without improvement of their thrombocytopenia. The investigational product, AMG 531, binds to the thrombopoietin receptor on megakaryocytes and stimulates new platelet production. The study drug is administered subcutaneously once a week for 12 weeks. After 12 weeks, the drug is discontinued, and platelet counts are monitored, weekly, for an additional 12 weeks. Once the platelet count has dropped below 50,000/mL (or subject is 36 weeks post study entrance) the subject will complete the study.