A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
Public ClinicalTrials.gov record NCT02246218. 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
An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)
Study identification
- NCT ID
- NCT02246218
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Amgen
- Industry
- Enrollment
- 27 participants
Conditions and interventions
Conditions
Interventions
- RAVICTI Drug
Drug
Eligibility (public fields only)
- Age range
- 1 Day to 2 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
- Dec 30, 2014
- Primary completion
- Oct 16, 2016
- Completion
- Jul 16, 2017
- Last update posted
- Jun 30, 2024
2014 – 2017
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kaiser Permanente Regional Metabolic Center | Los Angeles | California | 90027 | — |
| Stanford Center for Clinical & Translational Research & Education | Palo Alto | California | 94034 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Shands at University of Florida | Gainesville | Florida | 32610 | — |
| Emory University | Decatur | Georgia | 30033 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| Children's Hospital of Michigan | Detroit | Michigan | 48201 | — |
| 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 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
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 NCT02246218, 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 Jun 30, 2024 · Synced May 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02246218 live on ClinicalTrials.gov.