CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 19 enrolled
Drug / intervention
asfotase alfa +1 moredrug
Likely dose
asfotase alfa 0.3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01163149
NCT01163149Phase 2Completed
CompareCT.gov

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

Alexion Pharmaceuticals, Inc.·interventional·Posted Jul 15, 2010·Updated Mar 13, 2019

In Brief

A Phase 2 clinical trial evaluating asfotase alfa for Hypophosphatasia. Completed, enrolled 19 participants across 3 sites in 2 countries.

Detailed Summary

This clinical trial was conducted to study hypophosphatasia (HPP), a bone disorder caused by gene mutations or changes. These gene mutations cause low levels of an enzyme needed to harden bone. The purpose of this study was to test the safety and efficacy of two doses of the study drug called asfotase alfa as compared to a control group to see effects on adolescents and adults with HPP.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatasia
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 15, 2010
Enrollment StartJun 1, 2010
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6 yearsPosted 16.0 years ago

Interventions

asfotase alfadrug

Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week)

asfotase alfadrug

Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total)