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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.
Study identification
- NCT ID
- NCT00925054
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- 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
- Sep 2009 (Type not available)
- Primary completion
- Jun 2015 (Actual)
- Completion
- Jun 2015 (Actual)
- Last update posted
- Feb 26, 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 26, 2019 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00925054 live on ClinicalTrials.gov.