clinical trial · NCT01981720
Extension Study of PRX-102 for up to 60 Months
Protalix·phase2·completed·n = 15
Fabry DiseasePRX-102 (pegunigalsidase alfa)
brief summary
To evaluate the ongoing safety, tolerability, and efficacy parameters of PRX-102 in adult Fabry patients who have successfully completed treatment with PRX-102 in studies PB-102-F01 and PB-102-F02.
started
Jan 16, 2014
primary completion
Aug 26, 2020
completion
Nov 9, 2021
last updated
Sep 13, 2023
detailed description
An open-label study to evaluate the ongoing safety, tolerability and efficacy parameters of PRX-102 in adult Fabry patients (≥18 years of age). Patients enrolled received 1.0 mg/kg of PRX-102 as an intravenous infusion every 2 weeks (+/- 3 days) for up to 60 months and no less than 36 months.
official title
A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol