Trials / Terminated
TerminatedNCT03364738
Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism
An Open-label Study Investigating the Safety and Efficacy of rhPTH(1-84) in Subjects With Hypoparathyroidism
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | rhPTH(1-84) | Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD. |
Timeline
- Start date
- 2018-09-26
- Primary completion
- 2020-04-14
- Completion
- 2020-04-14
- First posted
- 2017-12-07
- Last updated
- 2022-10-07
- Results posted
- 2021-06-16
Locations
10 sites across 4 countries: United States, Canada, Denmark, Hungary
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03364738. Inclusion in this directory is not an endorsement.