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Dose Escalation Study to Evaluate the Safety and Tolerability of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP)

Hypophosphatasia Clinical Trial

Official title:
An Open-label, Intra-patient Dose-escalation Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Multiple Infusions of BPS804 in Adults With Hypophosphatasia (HPP).

Clinical Trial Summary

The purpose of the study is to determine tolerability, PK/PD and preliminary efficacy of BPS804 in adult patients with HPP treated with multiple escalating doses of BPS804. This study will allow a comparison of several doses of the study drug within the first two weeks after administration and after a longer assessment period for the highest dose level to enable selection of dose ranges to be tested in subsequent studies in the HPP indication.

Clinical Trial Description

This study was conducted and previously posted by Novartis. The record was transferred to Ultragenyx in February 2021. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01406977
Study type Interventional
Source Ultragenyx Pharmaceutical Inc
Contact
Status Completed
Phase Phase 2
Start date July 2011
Completion date September 2012
View Details
See also
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