Safety in Hemolytic PNH Patients Treated with Eculizumab: A Multi-center Open-label Research Design Study - SHEPHERD

ALEXION PHARMACEUTICALS INCORPORATED0 个研究点目标入组 85 人开始时间: 2004年12月9日最近更新: 2012年5月8日

研究概览

暂无简介。

•1. Individuals at least 18 years of age
•2. Patients with a diagnosis of PNH > 6 months
•3. Presence of a GPI deficient red blood cell clone (type III cells) by flow cytometry equal to or greater than 10%
•4. Patients must have
•- at least one transfusion in the past two years for anemia or anemia-related symptoms
•- personal beliefs that preclude the use of transfusion, with severe hemolytic PNH
•5. Documented LDH level greater than or equal to 1.5 times upper limit of normal within 12 weeks of Visit 1 or during the screening period
•6. Patients must avoid conception during the trial using a method that is most appropriate for their physical state and culture
•7. Patients must be willing and able to give written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Platelet count of < 30,000 per cubic millimetre
•2. Absolute neutrophil count of less than or equal to 500 per microlitre
•3. Presence or suspicion of active bacterial infection, in the opinion of the investigator, at Visit 2 or recurrent bacterial infections
•4. Known or suspected hereditary complement deficiency
•5. History of bone marrow transplantation
•6. Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening
•7. Pregnant, breast-feeding or intending to conceive during the course of the study, including the Safety Follow-up Visits
•8. History of meningococcal disease
•9. Patients who are not vaccinated against Neisseria meningitidis at least 14 days prior to Visit 2
•10. Any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study

发起方

ALEXION PHARMACEUTICALS INCORPORATED