Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU
Public ClinicalTrials.gov record NCT00925054. 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
Phase 2, Open-Label Dose-Finding Study to Evaluate the Safety, Efficacy, and Tolerability of Multiple Subcutaneous (SC) Doses of rAvPAL-PEG in Subjects With PKU
Study identification
- NCT ID
- NCT00925054
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- BioMarin Pharmaceutical
- Industry
- Enrollment
- 40 participants
Conditions and interventions
Conditions
Interventions
- rAvPAL-PEG 0.001 mg/kg Drug
- rAvPAL-PEG 0.003 mg/kg Drug
- rAvPAL-PEG 0.01 mg/kg Drug
- rAvPAL-PEG 0.03 mg/kg Drug
- rAvPAL-PEG 0.1 mg/kg Drug
Drug
Eligibility (public fields only)
- Age range
- 16 Years to 55 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
- Aug 31, 2009
- Primary completion
- May 31, 2015
- Completion
- May 31, 2015
- Last update posted
- Feb 25, 2019
2009 – 2015
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Children's Hospital | Aurora | Colorado | 80045 | — |
| Emory Universty | Decatur | Georgia | 30033 | — |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | — |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55455 | — |
| Washington University Center for Applied Research Sciences | St Louis | Missouri | 63110 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| Mount Sinai School of Medicine | New York | New York | 10029 | — |
| Akron Children's Hospital | Akron | Ohio | 44308 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
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 NCT00925054, 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 Feb 25, 2019 · Synced Jul 23, 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 NCT00925054 live on ClinicalTrials.gov.