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NCT00947297 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT00947297: Completed Phase 3 study, sponsored by Amgen.
NCT00947297 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00947297, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication.
Interventions
- DRUG HPN-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2009-11 |
| Est. Completion | 2011-11 |
| Phase | Phase 3 |
What the finished NCT00947297 record still lists
NCT00947297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which HPN-100 is the first listed.
NCT00947297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00947297 about?
NCT00947297 is a clinical study titled "Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)". This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with ...
What is the current status of trial NCT00947297?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2009-11. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00947297?
The interventions under investigation include: HPN-100 (DRUG).
Who is sponsoring clinical trial NCT00947297?
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 NCT00947297's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 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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