At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
asfotase alfa +1 morebiological
Likely dose
asfotase alfa 2 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.
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)
In Brief
A Phase 2 clinical trial evaluating asfotase alfa for Hypophosphatasia (HPP). Completed, enrolled 13 participants across 2 sites in 2 countries.
Detailed Summary
This clinical trial studied the safety and efficacy of asfotase alfa in children with HPP compared to a historical control group.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatasia (HPP)
CountriesCanada, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 2009
Enrollment StartSep 2009
Primary CompletionJul 2010
TodayJul 2026
First PostedAug 6, 2009
Enrollment StartSep 1, 2009
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 16.9 years ago
Interventions
asfotase alfabiological
2 mg/kg subcutaneous injection three times per week for 6 months.
asfotase alfabiological
3 mg/kg subcutaneous injection three times per week for 6 months.