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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 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 88 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01257737
The ClinicalTrials.gov registry entry for NCT01257737 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 88 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.
NCT01257737 reports 0 study locations.
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.
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