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NCT02781844 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
A Phase 1 study, sponsored by Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02781844: Completed Phase 1 study, sponsored by Shire.
NCT02781844 is a Phase 1 study that has completed, run by Shire. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02781844, a Phase 1 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara® and in the EU as Natpar).
Primary Outcome
Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Tmax of baseline adjusted rhPTH(1-84) was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure.
Interventions
- DRUG 25mcg rhPTH(1-84)
- DRUG 50mcg rhPTH(1-84)
- DRUG 100mcg rhPTH(1-84)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2017-04-03 |
| Est. Completion | 2019-03-08 |
| Phase | Phase 1 |
What the finished NCT02781844 record still lists
NCT02781844 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which 25mcg rhPTH(1-84) is the first listed.
NCT02781844 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02781844 about?
NCT02781844 is a clinical study titled "Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism". This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84)...
What is the current status of trial NCT02781844?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2017-04-03. Estimated completion is 2019-03-08.
What interventions are being tested in trial NCT02781844?
The interventions under investigation include: 25mcg rhPTH(1-84) (DRUG), 50mcg rhPTH(1-84) (DRUG), 100mcg rhPTH(1-84) (DRUG).
Who is sponsoring clinical trial NCT02781844?
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 NCT02781844's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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