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
Phase of Trial: Phase III
Latest Information Update: 06 Mar 2018
At a glance
- Drugs Pegunigalsidase alfa (Primary) ; Agalsidase beta
- Indications Fabry's disease
- Focus Registrational; Therapeutic Use
- Acronyms BALANCE
- Sponsors Protalix Biotherapeutics
- 06 Mar 2018 According to a Protalix Biotherapeutics media release, the Company expects to finalize enrollment in this trial during 2018.
- 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.