Phase 3, Open-Label, Switch Over Study to Assess Safety, Efficacy & PK of Pegunigalsidase Alfa 2 mg/kg Administered Every 4 Weeks for 52 Weeks in Fabry Disease Patients Currently Treated With Enzyme Replacement Therapy: Fabrazyme® (Agalsidase Beta) or Replagal™ (Agalsidase Alfa)
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 18 Nov 2017
At a glance
- Drugs Pegunigalsidase alfa (Primary)
- Indications Fabry's disease
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms BRIGHT
- Sponsors Protalix Biotherapeutics
- 07 Jun 2017 Status changed from planning to not yet recruiting.
- 18 May 2017 New trial record
- 10 May 2017 According to a Protalix BioTherapeutics, the company has received FDA IND clearance to initiate a trial evaluating once monthly dosing of 2mg/kg of PRX-102 in Fabry patients.