At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 10 enrolled
Drug / intervention
asfotase alfabiological
Likely dose
Not stated in 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.
Extension Study of ENB-0040 (Human Recombinant Tissue-Nonspecific Alkaline Phosphatase Fusion Protein) in Severely Affected Infants and Young Children With Hypophosphatasia (HPP)
In Brief
A Phase 2 clinical trial evaluating asfotase alfa for Hypophosphatasia. Completed, enrolled 10 participants across 8 sites in 3 countries.
Detailed Summary
This clinical trial studied the long term safety and efficacy of asfotase alfa in infants and young children with infantile onset HPP who completed study ENB-002-08 (NCT00744042). Partial funding for this study was provided by the Office of Orphan Product Development (OOPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatasia
CountriesUnited Arab Emirates, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
First PostedSep 2010
Primary CompletionAug 2016
TodayJul 2026
First PostedSep 20, 2010
Enrollment StartApr 1, 2009
Primary CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 15.8 years ago
Interventions
asfotase alfabiological