Open Label Extension Study to Evaluate the Long-term Safety Tolerability and Pharmacodynamics of AT1001 in Patients with Fabry Disease - Extension Study of AT1001 in Fabry Disease

Amicus Therapeutics, Inc.0 个研究点目标入组 0 人开始时间: 2007年5月16日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•1.Subject completed the main treatment period of another Phase 2 trial of AT1001 in Fabry disease
•2.Women of childbearing potential must have a negative result on their pregnancy test
•3.Male and female subjects agree to use reliable methods of contraception during study treatment and for 4 weeks after study treatment termination
•4.Subject is willing and able to provide 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) no
•F.1.3.1 Number of subjects for this age range

•1. Subject had a major protocol violation in the preceding AT1001 trial and was discontinued.
•2.Subject has undergone, or is scheduled to undergo kidney transplantation or is currently on dialysis
•3.Subject is treated or has been treated with another investigational drug (except AT1001) within 30 days of study start
•4.Subject has been treated with Fabrazyme (agalsidase beta), Replagal (agalsidase alfa), Glyset (miglitol) or Zavesca(miglustat) within 2 weeks prior to enrollment

发起方