Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102)in Patients With Fabry Disease

Chiesi Farmaceutici S.p.A0 个研究点目标入组 110 人开始时间: 2019年7月24日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. Completion of study PB-102-F20 or PB-102-F30, or completed at least 48 months in study PB-102-F03.
•2. The patient signs informed consent
•3. Female patients and male patients whose co-partners are of
•childbearing potential agree to use a medically ccepted, highly effective method of contraception. These include combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal) supplemented with a barrier method (preferably male condom), progestogen-only hormonal contraception associated with inhibition of ovulation (oral,
•injectable, or implantable) supplemented with a barrier method
•(preferably male condom), intrauterine device (IUD), intrauterine
•hormone-releasing system (IUS), bilateral tubal occlusion, vasectomised partner, or sexual abstinence. Contraception should be used for 2 weeks after treatment termination.
•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 110
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator, would interfere with patient compliance with the requirements of the study.

发起方