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NCT01347073 · ClinicalTrials.gov registry record · Phase 3
Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)
A Phase 3 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 3
- Development phase
- 23
- Enrollment target
NCT01347073: Completed Phase 3 study, sponsored by Amgen.
NCT01347073 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 23 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01347073, a Phase 3 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 23 participants
- Enrollment target
Study Summary
This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving monthly visits.
Primary Outcome
Rate of adverse events during the Switch-Over portion of the Protocol
Interventions
- DRUG HPN-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
What the finished NCT01347073 record still lists
NCT01347073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which HPN-100 is the first listed.
NCT01347073 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01347073 about?
NCT01347073 is a clinical study titled "Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)". This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving monthly visits.
What is the current status of trial NCT01347073?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 23 participants. The study started on 2011-07. Estimated completion is 2013-03.
What interventions are being tested in trial NCT01347073?
The interventions under investigation include: HPN-100 (DRUG).
Who is sponsoring clinical trial NCT01347073?
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 NCT01347073's enrollment target sits among peer trials
23 1952nd of 2000 higher than 48 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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