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NCT00947544 · ClinicalTrials.gov registry record · Phase 2
Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders
A Phase 2 study, sponsored by Amgen.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00947544 is a Phase 2 study that has completed, run by Amgen. The registered enrollment target is 17 participants.
The verdict
NCT00947544, a Phase 2 study, has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
Protocol HPN-100-005 was the first study of HPN-100 in pediatric subjects with urea cycle disorders (UCDs) and was a fixed-sequence, open-label, switch over study of HPN-100 with a long-term (12 month) safety extension designed to assess the safety of HPN-100 and to prospectively assess its ability to control blood ammonia as compared with Sodium Phenylbutyrate (NaPBA). Upon DSMB review of the first ten subjects who completed the switch over part of the study, and with DSMB approval, up to an additional 20 subjects were enrolled into the safety extension part of the study. HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4mL) delivers an equivalent amount of PBA to 40 tablets of NaPBA.
Interventions
- DRUG HPN-100
- DRUG NaPBA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00947544
The ClinicalTrials.gov registry entry for NCT00947544 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 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 2 interventions - of which HPN-100 is the first listed.
NCT00947544 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00947544 about?
NCT00947544 is a clinical study titled "Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders". Protocol HPN-100-005 was the first study of HPN-100 in pediatric subjects with urea cycle disorders (UCDs) and was a fixed-sequence, open-label, switch over study of HPN-100 with a long-term (12 month) safety extension designed to assess the safety of HPN-100 and to prospectively assess its ability ...
What is the current status of trial NCT00947544?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2010-03. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00947544?
The interventions under investigation include: HPN-100 (DRUG), NaPBA (DRUG).
Who is sponsoring clinical trial NCT00947544?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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