Randomized, Double-Blind, and Placebo-Controlled Study Using Eculizumab in Transfusion Dependent PNH Patients

Alexion Pharmaceuticals, Inc.84 个研究点分布在 12 个国家目标入组 75 人开始时间: 2004年10月最近更新: 2006年12月4日

适应症

试验速览

The primary objective is to evaluate the safety and efficacy of eculizumab in transfusion dependent patients with hemolytic PNH.

•Must have required at least 4 transfusions in the past 12 months
•PNH type III red blood cell (RBC) clone by flow cytometry of >10%
•Lactate dehydrogenase (LDH) level > 1.5 x upper limit of normal
•Platelet count > 100,000/mm3
•Patient taking erythropoietin must be on a stable dose for at least 26 weeks
•Patient taking immunosuppressants must be on a stable dose for at least 26 weeks
•Patient taking corticosteroids must be on a stable dose for at least 4 weeks
•Patient taking coumadin must be at a stable INR for at least 4 weeks
•Patient taking iron supplements or folic acid must be on a stable dose for 4 weeks
•Willing and able to give written informed consent
•Must avoid conception

•Mean hemoglobin level prior to transfusion over the previous 12 months is >10.5 gm/dl
•Absolute neutrophil count <500/ul
•Active bacterial infection
•Hereditary complement deficiency
•Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedures within 30 days
•Pregnant, breast-feeding, or intending to conceive
•History of meningococcal disease
•History of bone marrow transplantation

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