EUCTR2013-003262-13-DE进行中（未招募）1 期
A Phase III Open Label, Multicenter, Extension Study to Assess the Safety and Efficacy of Recombinant Coagulation Factor VIII (rVIII-SingleChain, CSL627) in Subjects with Severe Hemophilia A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •Males of any age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%) and who participated in a previous CSL-sponsored clinical study with rVIII-SingleChain.
- •Males 0 to <65 years age who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%), who have at least 50 EDs to any FVIII product, and who are not currently enrolled in a CSL-sponsored clinical study with rVIII-SingleChain.
- •Males 0 to <18 years of who have been diagnosed with severe congenital hemophilia A (FVIII activity levels < 1%).
- •No prior exposure to any Factor VIII product (with the exception of short-term use of blood products).
- •ITI substudy:
- •PUPs who have developed a confirmed inhibitor to rVIII-SingleChain in the main study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 129
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 121
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known or suspected hypersensitivity to rVIII-SingleChain or to any
- •excipients of rVIII-SingleChain or Chinese hamster ovary (CHO)
- •Currently receiving a therapy not permitted during the study.
- •Serum creatinine > 2 x upper limit of normal, alanine aminotransferase
- •or aspartate aminotransferase > 5 x upper limit of normal at Screening
- •(if specified)
- •Any first-order family (eg, siblings) history of FVIII inhibitors
- •For PTPs not rolling over directly from a CSL-sponsored clinical study
- •with rVIII-SingleChain: any history of or current FVIII inhibitors
研究者
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