A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in patients with hypophosphatasia (HPP)

Trial Profile

A Multicenter study of the safety and efficacy of Asfotase Alfa (ALXN1215) (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in patients with hypophosphatasia (HPP)

Completed
Phase of Trial: Phase II

Latest Information Update: 12 May 2016

At a glance

  • Drugs Asfotase alfa (Primary)
  • Indications Hypophosphatasia
  • Focus Adverse reactions
  • Most Recent Events

    • 02 Sep 2015 Status changed from recruiting to completed, as reported by University Hospital Medical Information Network - Japan record.
    • 06 Jul 2015 According to an Alexion Pharmaceuticals media release, Japan's Ministry of Health, Labour and Welfare has approved the NDA for asfotase alfa [Strensiq] for the treatment of patients with hypophosphatasia in Japan based on the data from three pivotal prospective trials and their extensions, a retrospective natural history study in infants and one investigator-sponsored study in Japan.
    • 12 Aug 2014 New trial record
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