Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)
Public ClinicalTrials.gov record NCT01347073. 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 Switch-Over, Open-Label Study of the Safety, Pharmacokinetics, and Efficacy of HPN-100, Followed by Long-Term Treatment With HPN-100, in Pediatric Subjects Under 6 Years of Age With Urea Cycle Disorders (UCDs)
Study identification
- NCT ID
- NCT01347073
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Amgen
- Industry
- Enrollment
- 23 participants
Conditions and interventions
Conditions
Interventions
- HPN-100 Drug
Drug
Eligibility (public fields only)
- Age range
- 29 Days to 6 Years
- 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
- Jun 30, 2011
- Primary completion
- Jan 31, 2013
- Completion
- Feb 28, 2013
- Last update posted
- Jul 10, 2024
2011 – 2013
United States locations
- U.S. sites
- 8
- U.S. states
- 8
- U.S. cities
- 8
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Pediatrics/Genetics | Los Angeles | California | 90404 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Maine Medical Center | Portland | Maine | 04101 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01347073, 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 May 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01347073 live on ClinicalTrials.gov.