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)
Status:
Completed
Phase of Trial:
Phase II
Latest Information Update: 02 Nov 2023
Price :
$35
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At a glance
- Drugs Asfotase alfa (Primary)
- Indications Hypophosphatasia
- Focus Registrational; Therapeutic Use
- Sponsors Alexion AstraZeneca Rare Disease
- 18 Mar 2019 Pooled results from this and five other studies were presented at the 101st Annual Meeting of the Endocrine Society.
- 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.