At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 42 enrolled
Drug / intervention
NPSP558drug
Likely dose
NPSP558 50 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 Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism
In Brief
A Phase 3 clinical trial evaluating NPSP558 for Hypoparathyroidism. Completed, enrolled 42 participants across 12 sites.
Detailed Summary
Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypoparathyroidism
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2010
Enrollment StartFeb 2011
Primary CompletionSep 2011
Study CompletionNov 2011
TodayJul 2026
First PostedDec 29, 2010
Enrollment StartFeb 9, 2011
Primary CompletionSep 23, 2011
Study CompletionNov 11, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.5 years ago
Interventions
NPSP558drug
All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.