NCT02910466

A Study of Extended Use of Recombinant Human Parathyroid Hormone (rhPTH(1-84)) in Hypoparathyroidism

A Phase 4, Open-Label, Single-Center Clinical Study of Extended Use of rhPTH(1-84) in Hypoparathyroidism

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhPTH(1-84) is a potential treatment option. The group of participants in the AAAE0544 core study has been taking rhPTH(1-84) for the treatment of hypoparathyroidism for up to 11 years. This study is designed to extend this experience and gain knowledge about how safe and effective rhPTH(1-84) is in participants with hypoparathyroidism over a long-term duration.

Conditions

• Chronic Hypoparathyroidism
• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	rhPTH(1-84)	Participants will receive 25, 50, 75, and 100 microgram (mcg) of rhPTH(1-84) subcutaneous injection to the thigh via a multidose pen injector device once daily for 36 months. The dose will be individualized based on Albumin-corrected Serum Calcium (ACSC) and 24-hour calcium urinary excretion to achieve a serum calcium level in the lower half of the normal range.

Timeline

• Start date: 2016-10-27
• Primary completion: 2019-12-20
• Completion: 2019-12-20
• First posted: 2016-09-22
• Last updated: 2021-07-28
• Results posted: 2021-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study