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NCT01257737 · ClinicalTrials.gov registry record · Phase 4
To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
NCT01257737: Completed Phase 4 study, sponsored by Amgen.
NCT01257737 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 88 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01257737, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
Study Summary
This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover studies, and their associated safety extensions were 12-month, open-label studies. All participants who completed the initial studies were eligible to enroll in the associated safety extension studies, and new participants were also permitted to enroll directly into the safety extension studies.
Primary Outcome
Safety was assessed by the incidence of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (SAEs). An AE/adverse experience was any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. For additional information regarding adverse events, please see the safety section of the record.
Interventions
- DRUG HPN-100
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2010-10-04 |
| Est. Completion | 2017-02-16 |
| Phase | Phase 4 |
What the finished NCT01257737 record still lists
NCT01257737 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which HPN-100 is the first listed.
NCT01257737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01257737 about?
NCT01257737 is a clinical study titled "To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs)". This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or HPN-100-012 (NCT01347073; HPN-100-...
What is the current status of trial NCT01257737?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2010-10-04. Estimated completion is 2017-02-16.
What interventions are being tested in trial NCT01257737?
The interventions under investigation include: HPN-100 (DRUG).
Who is sponsoring clinical trial NCT01257737?
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 NCT01257737's enrollment target sits among peer trials
88 916th of 2000 higher than 1,078 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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