NCT01297309

A 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)

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.

Detailed description

Patients with a history of Hypoparathyroidism will be enrolled to receive study drug for up to 80 months, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	NPSP558	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.

Timeline

• Start date: 2011-04-06
• Primary completion: 2018-06-08
• Completion: 2018-06-08
• First posted: 2011-02-16
• Last updated: 2021-05-25
• Results posted: 2019-08-06

Locations

14 sites across 1 country: United States