Open Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegunigalsidase Alfa (PRX-102) 2 mg/kg Administered by Intravenous Infusion Every 4 Weeks in Patients with Fabry Disease

Chiesi Farmaceutici S.p.A0 个研究点目标入组 28 人开始时间: 2019年6月13日最近更新: 2024年7月15日

研究概览

暂无简介。

•1. Completion of study PB-102-F50.
•2. The patient signs informed consent.
•3. Female patients and male patients whose co-partners are of child-bearing 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 28
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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