Trials / Withdrawn

WithdrawnNCT04189315

Relieving Burden of Hypophosphatasia in Adults With Functional Impairment Due to Chronic Disease

A Phase 4, Randomized, Multicenter, Open-Label, 2-Dosage Regimen, Safety and Tolerability, Efficacy, Pharmacokinetic, and Pharmacodynamic Study of Asfotase Alfa in Adult Patients With Pediatric-Onset Hypophosphatasia

Status: Withdrawn
Phase: Phase 4
Study type: Interventional
Enrollment: 0 (actual)

Sponsor: Alexion Pharmaceuticals, Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

The study will evaluate safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of 2 different doses (approved dose and lower dose) of asfotase alfa in adult participants with pediatric-onset hypophosphatasia (HPP).

Conditions

Hypophosphatasia

Interventions

Type	Name	Description
DRUG	asfotase alfa	Asfotase alfa is administered subcutaneously.

Timeline

Start date: 2020-04-01
Primary completion: 2022-08-01
Completion: 2022-08-01
First posted: 2019-12-06
Last updated: 2020-06-04

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT04189315. Inclusion in this directory is not an endorsement.