At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 51 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.
A Long-term 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 (RACE)
In Brief
A Phase 3 clinical trial evaluating NPSP558 for Hypoparathyroidism. Completed, enrolled 51 participants across 14 sites.
Detailed Summary
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoparathyroidism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartApr 2011
Primary CompletionJun 2018
TodayJul 2026
First PostedFeb 16, 2011
Enrollment StartApr 6, 2011
Primary CompletionJun 8, 2018
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 15.4 years ago
Interventions
NPSP558drug
All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.