CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 12 enrolled
Drug / intervention
Ilofotase Alfa, 0.8 mg/kg +1 morebiological
Likely dose
Ilofotase Alfa, 0.8 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/NCT05890794
NCT05890794Phase 2Completed
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Open-Label Pilot Trial to Evaluate the Effects of Ilofotase Alfa on Biomarkers in Adult Patients With Hypophosphatasia

AM-Pharma·interventional·Posted Jun 6, 2023·Updated Feb 27, 2025

In Brief

A Phase 2 clinical trial evaluating Ilofotase Alfa, 0.8 mg/kg and Ilofotase Alfa, 3.2 mg/kg for Hypophosphatasia. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The goal of this clinical trial is to compare the effectiveness of two doses of ilofotase alfa, an enzyme replacement treatment, in patients with hypophosphatasia (HPP). The main question it aims to answer is if the harmful accumulating levels of extracellular inorganic pyrophosphate (PPi) and pyridoxal 5'-phosphate (PLP) can be reduced with ilofotase alfa. Researchers will compare the two doses of ilofotase alfa to see if treatment effects differ between the doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypophosphatasia
CountriesGermany
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedJun 6, 2023
Enrollment StartMay 15, 2023
Primary CompletionJul 7, 2023
Study CompletionJul 12, 2023
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 3.1 years ago

Interventions

Ilofotase Alfa, 0.8 mg/kgbiological

Biological: single 1-hour intravenous infusion of 0.8 mg/kg ilofotase alfa

Ilofotase Alfa, 3.2 mg/kgbiological

Biological: single 1-hour intravenous infusion of 3.2 mg/kg ilofotase alfa