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)

Trial Profile

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: 16 Jun 2017

At a glance

  • Drugs Pegunigalsidase alfa (Primary)
  • Indications Fabry's disease
  • Focus Adverse reactions; Registrational
  • Acronyms BRIGHT
  • Sponsors Protalix Biotherapeutics
  • Most Recent Events

    • 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.
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