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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)

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)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2019

At a glance

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

    • 05 Feb 2019 According to a Protalix Biotherapeutics media release, as of December 23, 2018, 28 patients had been enrolled in the BRIGHT study, and 15 of those patients had completed 9 months of treatment. Samples from these 15 patients underwent pharmacokinetic (PK) evaluation and were tested for the presence of anti-drug antibodies (ADA).
    • 05 Feb 2019 Results presented in a Protalix BioTherapeutics media release.
    • 28 Jan 2019 According to a Protalix Biotherapeutics media release, preliminary pharmacokinetic (PK) data (N=15) will be presented at the 15th Annual WORLDSymposium 2019.
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