A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Weeks to Adult Fabry Patients
Phase of Trial: Phase I/II
Latest Information Update: 08 Aug 2019
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At a glance
- Drugs Pegunigalsidase alfa (Primary)
- Indications Fabry's disease
- Focus Adverse reactions; First in man; Pharmacokinetics
- Sponsors Protalix Biotherapeutics
- 08 Aug 2019 According to a Protalix Biotherapeutics media release, results from this trial were published Journal of Inherited Metabolic Disease.
- 10 May 2017 According to a Protalix Biotherapeutics media release, results from this trial were presented at the World Congress of Nephrology 2017, titled, The Fifth Update on Fabry Nephropathy.
- 09 May 2017 Results of pharmacokinetic analysis and modeling, which provides a strong rationale for once-monthly dosing of PRX-102, published in a Protalix BioTherapeutics Media Release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History