A Phase 2a, Open-Label, Sequential Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112 (Plant Recombinant Human Glucocerebrosidase) in Enzyme Replacement Therapy-Naïve Subjects With Gaucher Disease.

Trial Profile

A Phase 2a, Open-Label, Sequential Dose Escalation Study to Evaluate the Safety and the Pharmacokinetics of Oral PRX-112 (Plant Recombinant Human Glucocerebrosidase) in Enzyme Replacement Therapy-Naïve Subjects With Gaucher Disease.

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Oct 2016

At a glance

  • Drugs Taliglucerase alfa (Primary)
  • Indications Gaucher's disease
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Protalix Biotherapeutics
  • Most Recent Events

    • 27 Sep 2016 Status changed from recruiting to completed.
    • 12 Mar 2015 According to a Protalix BioTherapeutics media release, the last patient in this trial trial was treated in Feb 2015.
    • 25 Jul 2014 Status changed from not yet recruiting to recruiting according to the Protalix Biotherapeutics media release.
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