Multicenter and dose escalation phase 1 study to evaluate the safety and exploratory efficacy of GC1119 (recombinant human a-galactosidase A) for enzyme replacement therapy in Fabry disease patients

Green Cross0 个研究点目标入组 10 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1) Subjects with a current diagnosis of Fabry's disease
•(leukocyte a-gal activity of = 10 mnol/hr/ml and a mutation in a-galactosidase A gene)
•2) Males = 16 years old
•3) Subjects capable of performing this clinical trial in an appropriate manner
•4) Informed consent form voluntarily signed by the subject(or his legally acceptable representative if the subject is under 20 years old) to participation in the study
•5) Agreement to contraception during the study period

•1) Serum creatinine > 2.5mg/dl
•2) Subjects have a plan to kidney transplantation
•3) Subjects have undergone kidney transplantation
•4) Subjects are currently on dialysis
•5) Subjects have a clinically significant organic disease(cardiovascular, hepatic, pulmonary, neurologic, or renal disease)that in the opinion of the investigator would preclude participation in the trial
•6) Known life-threatening hypersensitivity(anaphylactic reaction) to a-galactosidase
•7) Treatment with another investigational product within 30days from the administration of study drug dosing or plans to be treated with another investigational product during the study period
•8) Known hypersensitivity to any of the ingredients of study drug(including excipients)
•9) Subjects need the medication of prohibited drug
•10) Alcoholism or drug addiction

发起方

Green Cross