NCT01981720

Extension Study of PRX-102 for up to 60 Months

A Multi Center Extension Study of PRX-102 Administered by Intravenous Infusions Every 2 Weeks for up to 60 Months to Adult Fabry Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Protalix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Fabry Disease

Interventions

Type	Name	Description
BIOLOGICAL	PRX-102 (pegunigalsidase alfa)	PRX-102 1 mg/kg every 2 weeks

Timeline

• Start date: 2014-01-16
• Primary completion: 2020-08-26
• Completion: 2021-11-09
• First posted: 2013-11-11
• Last updated: 2023-09-13
• Results posted: 2023-02-08

Locations

8 sites across 4 countries: United States, Paraguay, Spain, United Kingdom

Regulatory

• FDA-regulated drug study