drugset / Trial / NCT01455181

A Study to Investigate the Safety and Tolerability of NPSP558, for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study in Hungary

NCT01455181 ↗

Phase 3 Completed 24 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

This study is designed to evaluate the effect of 6-months of treatment with NPSP558 in reducing requirements for supplemental oral calcium and active vitamin D, while maintaining stable total serum calcium levels in adult subjects with hypoparathyroidism.

Timeline

Start
2011-08-19
Primary completion
2012-04-26
Completion
2012-04-26

Outcome

Met primary endpoint

paper At Week 24, 75% of patients (95% confidence interval [CI], 53.3-90.2%) achieved the study endpoint; PMID 26684150 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Parathyroid Hormone Protein / enzyme biologic 50 ug —
Subject Parathyroid Hormone Protein / enzyme biologic 75 ug —
Subject Parathyroid Hormone Protein / enzyme biologic 100 ug —

Indications