drugset / Trial / NCT03364738

Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism

NCT03364738

Phase 3 Terminated 22 enrolled Shire
NaSingle-groupOpen-labelTreatment

Summary

This study is open to adults with hypoparathyroidism who complete the SHP634-101 study (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in adults with hypoparathyroidism who previously participated in the SHP634-101 study. All participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an injection. Patients who complete the SHP634-101 study will have the option to screen for this extension study.

Timeline

Start
2018-09-26
Primary completion
2020-04-14
Completion
2020-04-14

Drugs

EvaluationDrugModalityDoseRoute
Subject Parathyroid Hormone Protein / enzyme biologic 25 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 50 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 75 ug Subcutaneous
Subject Parathyroid Hormone Protein / enzyme biologic 100 ug Subcutaneous

Indications