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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 is a Phase 3 study that has completed, run by Amgen. The registered enrollment target is 23 participants.
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.
Interventions
- DRUG HPN-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01347073
The ClinicalTrials.gov registry entry for NCT01347073 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 23 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.
NCT01347073 reports 0 study locations.
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.
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