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NCT00992459 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
NCT00992459: Completed Phase 3 study, sponsored by Amgen.
NCT00992459 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 46 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00992459, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
Study Summary
This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA.
Primary Outcome
Blood samples were collected at pre-dose, 2, 4, 8, 12, 16, 20 and 24 hours after first dose on days 14 and 28. Arm A day 14 and Arm B day 28 data were combined as a NaPBA treatment Arm. Arm B day 14 and Arm A day 28 data were combined as a HPN-100 treatment Arm.
Interventions
- DRUG HPN-100
- DRUG Buphenyl (NaPBA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00992459 record still lists
NCT00992459 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which HPN-100 is the first listed.
NCT00992459 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00992459 about?
NCT00992459 is a clinical study titled "Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders". This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA.
What is the current status of trial NCT00992459?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2009-10. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00992459?
The interventions under investigation include: HPN-100 (DRUG), Buphenyl (NaPBA) (DRUG).
Who is sponsoring clinical trial NCT00992459?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00992459's enrollment target sits among peer trials
46 1868th of 2000 higher than 131 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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