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NCT01268098 · ClinicalTrials.gov registry record · Phase 3
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
A Phase 3 study, sponsored by Shire.
- Completed
- Registry status
- Phase 3
- Development phase
- 42
- Enrollment target
NCT01268098: Completed Phase 3 study, sponsored by Shire.
NCT01268098 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 42 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01268098, a Phase 3 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 42 participants
- Enrollment target
Study Summary
Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
Primary Outcome
The triple efficacy endpoint criteria were defined as a reduction from baseline in oral calcium to ≤ 500 mg/day, a reduction from baseline in calcitriol dose to ≤ 0.25 µg/day, and an albumin-corrected total serum calcium level between 7.5 mg/dL and the upper limit of the laboratory normal range. The analysis of primary endpoint was based on investigator prescribed data.
Interventions
- DRUG NPSP558
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2011-02-09 |
| Est. Completion | 2011-11-11 |
| Phase | Phase 3 |
What the finished NCT01268098 record still lists
NCT01268098 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which NPSP558 is the first listed.
NCT01268098 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01268098 about?
NCT01268098 is a clinical study titled "Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)". Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.
What is the current status of trial NCT01268098?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 42 participants. The study started on 2011-02-09. Estimated completion is 2011-11-11.
What interventions are being tested in trial NCT01268098?
The interventions under investigation include: NPSP558 (DRUG).
Who is sponsoring clinical trial NCT01268098?
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 NCT01268098's enrollment target sits among peer trials
42 1877th of 2000 higher than 124 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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