CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 24 enrolled
Drug / intervention
NPSP558drug
Likely dose
NPSP558 100 μgfrom 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/NCT01455181
NCT01455181Phase 3Completed

A 6-Month Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study

Shire·interventional·Posted Oct 19, 2011·Updated Jun 11, 2021

In Brief

A Phase 3 clinical trial evaluating NPSP558 for Hypoparathyroidism. Completed, enrolled 24 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 19, 2011
Enrollment StartAug 19, 2011
Primary CompletionApr 26, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.7 years ago

Interventions

NPSP558drug

50, 75, 100 μg