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Pilot Trial of Single Dose Ilofotase Alfa in Hypophosphatasia

NCT05890794 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-02-27

Study results available
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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.

Conditions

  • Hypophosphatasia

Interventions

BIOLOGICAL

Ilofotase Alfa, 0.8 mg/kg

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

BIOLOGICAL

Ilofotase Alfa, 3.2 mg/kg

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

Sponsors & Collaborators

  • AM-Pharma

    lead INDUSTRY

Principal Investigators

  • Dr Seefried · Osteologie / Klinische Studieneinheit, Orthopädische Klinik - KLH, Würzburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-15
Primary Completion
2023-07-07
Completion
2023-07-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05890794 on ClinicalTrials.gov