At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 69 enrolled
Drug / intervention
asfotase alfadrug
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.
An Open-Label, Multicenter, Multinational Study of the Safety, Efficacy and Pharmacokinetics of Asfotase Alfa (Human Recombinant Tissue-nonspecific Alkaline Phosphatase Fusion Protein) in Infants and Children ≤ 5 Years of Age With Hypophosphatasia (HPP)
In Brief
A Phase 3 clinical trial evaluating asfotase alfa for Hypophosphatasia. Completed, enrolled 69 participants across 23 sites in 12 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 a study drug called asfotase alfa (human recombinant tissue non-specific alkaline phosphate fusion protein) to see what effects it has on patients 5 years of age or less with HPP.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatasia
CountriesAustralia, Canada, France, Germany, Italy, Japan, Russia, Saudi Arabia, Spain, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2010
First PostedAug 2010
Primary CompletionSep 2016
TodayJul 2026
First PostedAug 5, 2010
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 15.9 years ago
Interventions
asfotase alfadrug