A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Historical Control Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Children With Hypophosphatasia (HPP)

Trial Profile

A Randomized, Open-Label, Multicenter, Multinational, Dose-Ranging, Historical Control Study of the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of ENB-0040 (Human Recombinant Tissue Nonspecific Alkaline Phosphatase Fusion Protein) in Children With Hypophosphatasia (HPP)

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Apr 2017

At a glance

  • Drugs Asfotase alfa (Primary)
  • Indications Hypophosphatasia
  • Focus Registrational; Therapeutic Use
  • Sponsors Alexion Pharmaceuticals
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 04 Apr 2017 Results of 6 minute walk test from 2 phase 2 trials (n=23, NCT00952484 and NCT01163149) presented at The 99th Annual Meeting of the Endocrine Society
    • 29 Mar 2016 Primary endpoints amended. Time frame for efficacy endpoint changed. Safety endpoint deleted from trial.Hence, trial focus changed from TU, AR to TU.
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