drugset / Trial / NCT03364738
Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |