Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)
Public ClinicalTrials.gov record NCT00947297. 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, Open-Label Study of the Safety of HPN-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a long-term safety study HPN-100 in urea cycle disorder (UCD) subjects. Subjects were assessed regularly for safety and control of their venous ammonia. Hyperammonemic events were characterized with respect to contributing factors, such as intercurrent illness, diet, and noncompliance with medication.
Study identification
- NCT ID
- NCT00947297
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 60 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 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
- Nov 2009 (Type not available)
- Primary completion
- Sep 2011 (Actual)
- Completion
- Nov 2011 (Actual)
- Last update posted
- Jul 10, 2024
2009 – 2011
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 | 94305 | — |
| Children's Hospital Colorado | 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 | — |
| Univeristy 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 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15260 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Utah | Salt Lake City | Utah | 84112 | — |
| 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 NCT00947297, 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 10, 2024 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00947297 live on ClinicalTrials.gov.