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NCT01297309 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 51
- Enrollment target
NCT01297309: Completed Phase 3 study, sponsored by Shire.
NCT01297309 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 51 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01297309, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 51 participants
- Enrollment target
Study Summary
This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
Primary Outcome
SAE is an adverse event (AE) that results in death, life threatening, persistent or significant incapacity or substantial disruption of ability to conduct normal life functions, hospitalization or prolongation of existing hospitalization, congenital anomaly or birth defect, important medical events that may not result in death, be life threatening, or require hospitalization. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a
Interventions
- DRUG NPSP558
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-04-06 |
| Est. Completion | 2018-06-08 |
| Phase | Phase 3 |
What the finished NCT01297309 record still lists
NCT01297309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which NPSP558 is the first listed.
NCT01297309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01297309 about?
NCT01297309 is a clinical study titled "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)". This study is a long-term, open-label study using NPSP558 for the treatment of adult patients with Hypoparathyroidism.
What is the current status of trial NCT01297309?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 51 participants. The study started on 2011-04-06. Estimated completion is 2018-06-08.
What interventions are being tested in trial NCT01297309?
The interventions under investigation include: NPSP558 (DRUG).
Who is sponsoring clinical trial NCT01297309?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01297309's enrollment target sits among peer trials
51 1842nd of 2000 higher than 157 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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