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NCT03335488 · ClinicalTrials.gov registry record · Phase 4
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)
A Phase 4 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 4
- Development phase
- 16
- Enrollment target
NCT03335488: Completed Phase 4 study, sponsored by Amgen.
NCT03335488 is a Phase 4 study that has completed, run by Amgen. The registered enrollment target is 16 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03335488, a Phase 4 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects not currently or previously chronically treated with phenylacetic acid (phenylacetate; PAA) prodrugs. The study design will include: 1) Baseline Period; 2) Initial Treatment Period; 3) a RAVICTI only Transition Period 4) a RAVICTI only Maintenance Period; and 5) a RAVICTI only Safety Extension Period. The study will run for approximately 25 weeks.
Primary Outcome
A participant was considered a Treatment Success for the assigned treatment arm if the participant had not experienced an unprovoked hyperammonemic crisis (HAC) (i.e., a HAC that cannot be attributed to one or more specific precipitating factors such as infection, intercurrent illness, diet noncompliance, treatment noncompliance, etc.) on the assigned treatment and had met at least 2 of the following 3 criteria: * Had absolute values at the 3 time points (pre-dose, after dose at 4 hours and 8 h
Interventions
- DRUG RAVICTI
- DRUG NaPBA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2018-02-20 |
| Est. Completion | 2022-12-20 |
| Phase | Phase 4 |
What the finished NCT03335488 record still lists
NCT03335488 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which RAVICTI is the first listed.
NCT03335488 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03335488 about?
NCT03335488 is a clinical study titled "Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)". This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects not currently or previously chronically treated with phenylacetic acid (p...
What is the current status of trial NCT03335488?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 16 participants. The study started on 2018-02-20. Estimated completion is 2022-12-20.
What interventions are being tested in trial NCT03335488?
The interventions under investigation include: RAVICTI (DRUG), NaPBA (DRUG).
Who is sponsoring clinical trial NCT03335488?
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 NCT03335488's enrollment target sits among peer trials
16 1869th of 2000 higher than 121 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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