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)

• Status: Completed
• Trial end date: 2018-06-08
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Hormones

Criteria

Inclusion Criteria:

• Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or previously completed the rhPTH[1-84] REPLACE study (Visit 18).

• Able to perform daily SC self-injections of study medication (or have a designee perform injection).

• Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing potential with a negative pregnancy test and who consent to use two acceptable methods of contraception for the duration of the study.

• Males who have female partners of childbearing potential must use two acceptable forms of contraception for the duration of the study.

• Serum creatinine <1.5 mg/dL at enrollment.

• Total serum calcium less than or equal to upper limit of normal (ULN) based on local laboratory result prior to enrollment.

• Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within approximately 16 weeks prior to enrollment.

Exclusion Criteria:

• Any condition that, in the investigator's opinion after consultation with the sponsor, would preclude the safe use of parathyroid hormone (PTH).

• Pregnant or lactating women.

• Any disease or condition which has a high probability of precluding the subject from completing the study or where the subject cannot or will not appropriately comply with study requirements.