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)
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Study Type: Interventional
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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)
Estimated Enrollment: 50
Study Start Date: April 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms:
- Experimental: NPSP558 (titration of 25, 50, 75 or 100 μg)
Category | Value |
---|---|
Date last updated at source | 2017-02-01 |
Study type(s) | Interventional |
Expected enrolment | 50 |
Study start date | 2011-04-01 |
Estimated primary completion date | 2018-01-01 |