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

CSL Behring GmbH0 个研究点目标入组 250 人开始时间: 2015年4月10日最近更新: 2021年4月5日

研究概览

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•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: 143
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 131
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 1

•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

发起方