临床试验/NCT00122317

NCT00122317已完成3 期

Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH

Alexion Pharmaceuticals, Inc.40 个研究点分布在 12 个国家目标入组 187 人开始时间: 2005年5月最近更新: 2018年3月13日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Alexion Pharmaceuticals, Inc.
入组人数: 187
试验地点: 40
主要终点: Incidence of Treatment-emergent Adverse Events

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

详细描述

An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients who have fully completed the TRIUMPH, SHEPHERD, or X03-001 studies
•TRIUMPH patients who have discontinued receiving investigational drug prior to the last visit of the study due to lack of efficacy or exacerbation of symptoms of PNH and have completed all monthly safety and efficacy procedures
•Patient must be willing and able to give written informed consent
•Patient must avoid conception during the trial

排除标准

•Patients who have terminated early from the SHEPHERD or X03-001 studies
•Patients who have terminated early from the TRIUMPH study due to an adverse event
•Female who is pregnant, breast feeding, or intending to conceive during the course of the study
•Any condition that could increase the patient's risk by participating in the study or could confound the outcome of the study

研究组 & 干预措施

Eculizumab

Experimental

600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks

干预措施: eculizumab (Drug)

结局指标

主要结局

Incidence of Treatment-emergent Adverse Events

时间窗: From time of consent to a maximum of 2.5 years of study treatment

次要结局

Hemolysis as Measured by Change From Baseline in LDH Area Under the Curve(From time of first infusion through 24 months of study treatment)
Incidence of Thrombosis After Eculizumab Infusion(From time of first ever dose through last dose (up to 24 months of study treatment))
Quality of Life as Measured by FACIT-Fatigue Scale Change From Baseline(From time of first infusion through 24 months of study treatment)

研究者

发起方

Alexion Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (40)

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