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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 60 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00947297
The ClinicalTrials.gov registry entry for NCT00947297 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HPN-100 is the first listed.
NCT00947297 reports 0 study locations.
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.
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