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

Trial Profile

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Pegunigalsidase alfa (Primary) ; Agalsidase beta
  • Indications Fabry's disease
  • Focus Registrational; Therapeutic Use
  • Acronyms BALANCE
  • Sponsors Protalix Biotherapeutics
  • Most Recent Events

    • 09 Aug 2017 According to a Protalix Biotherapeutics media release, a number of patients in the study has been moved to home care therapy following successful initial infusion periods in the infusion center.
    • 09 Jan 2017 According to a Protalix Biotherapeutics media release, the company expects to complete the enrollment in 2017 with interim data analysis anticipated in 2018 to support EMA and other regulatory filings outside of the United States.
    • 25 Oct 2016 According to a Protalix BioTherapeutics media release, first patient has been dosed in the study.
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