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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)

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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)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2019

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At a glance

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

    • Most Recent Events

    • 25 Sep 2019 Planned End Date changed from 1 Dec 2019 to 1 Dec 2020.
    • 25 Sep 2019 Planned primary completion date changed from 1 Aug 2019 to 1 Jul 2020.
    • 17 Jun 2019 According to a Protalix Biotherapeutics media release, to date, substantially all patients that were enrolled in the study remain on the 4-week dosing regimen, and all of the patients that completed the study opted (with the advice of the treating physician) to continue treatment under the 4-week dosing regimen in a long-term extension study
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