pegunigalsidase alfa

DRUG7 trials

Sponsors

Protalix, Chiesi Farmaceutici S.p.A., Chiesi Italia, Protalix Ltd

Conditions

Fabry DiseaseFabry disease lysosomal storage disease

Phase 3

A Randomized, Double blind, Active Control Study of the Safety and Efficacy of PRX-102 compared to Agalsidase Beta on Renal Function in Patients with Fabry Disease Previously Treated With Agalsidase Beta

Active, not recruitingNL-OMON45301

Protalix LtdFabry disease lysosomal storage disease

Start: 2017-10-05Target: 5Updated: 2024-02-28

Safety, Efficacy, & PK of PRX-102 in Patients With Fabry Disease Administered Intravenously Every 4 Weeks

CompletedNCT03180840

ProtalixFabry Disease

Start: 2017-07-10End: 2020-08-01Updated: 2023-09-13

An Open Label Study of the Safety and Efficacy of PRX 102 in Patients with Fabry Disease Currently Treated With REPLAGAL® (Agalsidase alfa)

Active, not recruitingNL-OMON47873

Protalix LtdFabry disease lysosomal storage disease

Start: 2018-08-07Target: 5Updated: 2024-02-28

Open Label Extension Study of 1 mg/kg Pegunigalsidase Alfa Every 2 Weeks in Patients With Fabry Disease

CompletedNCT03566017

Chiesi Farmaceutici S.p.A.Fabry Disease

Start: 2018-09-16End: 2025-01-21Updated: 2026-03-24

Open Label Extension of 2 mg/kg Pegunigalsidase Alfa (PRX-102) Every 4 Weeks in Adult Fabry Disease Patients

CompletedNCT03614234

Chiesi Farmaceutici S.p.A.Fabry Disease

Start: 2018-11-13End: 2026-04-13Updated: 2026-05-22

Unknown Phase

Open-Label Expanded Access Treatment With Pegunigalsidase Alfa for Fabry Disease Patients

Chiesi Farmaceutici S.p.A.Fabry Disease

Updated: 2024-07-31

Observational Study on Long-term Use of Pegunigalsidase Alfa in Fabry Patients in a Real-world Setting

RecruitingNCT07109375

Chiesi ItaliaFabry Disease

Start: 2026-06-15End: 2029-02-01Target: 75Updated: 2026-07-08

Related Papers

Long-term efficacy and safety of pegunigalsidase alfa administered every 4 weeks in adults with Fabry disease: results from up to 5 years of the BRIGHT F51 phase III, open-label extension study

Orphanet Journal of Rare Diseases2026-03-20

Health State Utility Values in Fabry Disease: Insights from the Pegunigalsidase Alfa Clinical Trials.

2025-01-23

A phase <scp>III</scp>, open‐label clinical trial evaluating pegunigalsidase alfa administered every 4 weeks in adults with Fabry disease previously treated with other enzyme replacement therapies

Journal of Inherited Metabolic Disease2024-10-0911 citations

Head-to-head trial of pegunigalsidase alfa versus agalsidase beta in patients with Fabry disease and deteriorating renal function: results from the 2-year randomised phase III BALANCE study.

2024-05-2134 citations

Safety and efficacy of pegunigalsidase alfa in patients with Fabry disease who were previously treated with agalsidase alfa: results from BRIDGE, a phase 3 open-label study.

2023-10-2121 citations