Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders
Public ClinicalTrials.gov record NCT00992459. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Cross-Over, Active-Controlled Study of the Efficacy and Safety of HPN-100, Glyceryl Tri-(4-phenylbutyrate), for the Treatment of Adults With Urea Cycle Disorders (Help UCD)
Study identification
- NCT ID
- NCT00992459
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Amgen
- Industry
- Enrollment
- 46 participants
Conditions and interventions
Conditions
Interventions
- Buphenyl (NaPBA) Drug
- HPN-100 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 30, 2009
- Primary completion
- Aug 31, 2010
- Completion
- Aug 31, 2010
- Last update posted
- Jul 8, 2024
2009 – 2010
United States locations
- U.S. sites
- 21
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Long Beach Memorial | Long Beach | California | 90806 | — |
| UCLA | Los Angeles | California | 90095 | — |
| Stanford University | Stanford | California | 94304 | — |
| Denver Children's Hospital | Aurora | Colorado | 80045 | — |
| Yale School of Medicine | New Haven | Connecticut | 06510 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Florida | Gainesville | Florida | 32611 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| SNBL-Clinical Pharmacology Center | Baltimore | Maryland | 21201 | — |
| Tufts-New England Medical Center | Boston | Massachusetts | 02111 | — |
| University of Minnesota Medical Center | Minneapolis | Minnesota | 55454 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Westchester Medical Center | Valhalla | New York | 10595 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00992459, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 8, 2024 · Synced May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00992459 live on ClinicalTrials.gov.