Sapropterin Expanded Access Program
Public ClinicalTrials.gov record NCT00484991. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Purpose of this study is to provide patients with hyperphenylalaninemia (HPA) due to Phenylketonuria (PKU) access to sapropterin dihydrochloride and to collect more information about the safety of the drug in an expanded access program (EAP) until commercial product is available.
Study identification
- NCT ID
- NCT00484991
- Recruitment status
- Approved For Marketing
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 9 Years and older
- Sex
- All
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Apr 15, 2008
United States locations
- U.S. sites
- 36
- U.S. states
- 21
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Not listed | Los Angeles | California | — | — |
| Not listed | Orange | California | — | — |
| Not listed | San Diego | California | — | — |
| Not listed | Stanford | California | — | — |
| Not listed | Denver | Colorado | — | — |
| Not listed | Gainseville | Florida | — | — |
| Not listed | Tampa | Florida | — | — |
| Not listed | Chicago | Illinois | — | — |
| Not listed | Indianapolis | Indiana | — | — |
| Not listed | Louisville | Kentucky | — | — |
| Not listed | New Orleans | Louisiana | — | — |
| Not listed | Bangor | Maine | — | — |
| Not listed | Boston | Massachusetts | — | — |
| Not listed | Minneapolis | Minnesota | — | — |
| Not listed | Columbia | Missouri | — | — |
| Not listed | Kansas City | Missouri | — | — |
| Not listed | St Louis | Missouri | — | — |
| Not listed | Newark | New Jersey | — | — |
| Not listed | Manhasset | New York | — | — |
| Not listed | Rochester | New York | — | — |
| Not listed | Stony Brook | New York | — | — |
| Not listed | Valhalla | New York | — | — |
| Not listed | Akron | Ohio | — | — |
| Not listed | Columbus | Ohio | — | — |
| Not listed | Hershey | Pennsylvania | — | — |
| Not listed | Philadelphia | Pennsylvania | — | — |
| Not listed | Pittsburgh | Pennsylvania | — | — |
| Not listed | Florence | South Carolina | — | — |
| Not listed | Sioux Falls | South Dakota | — | — |
| Not listed | Galveston | Texas | — | — |
| Not listed | Houston | Texas | — | — |
| Not listed | Salt Lake City | Utah | — | — |
| Not listed | Charlottesville | Virginia | — | — |
| Not listed | Norfolk | Virginia | — | — |
| Not listed | Madison | Wisconsin | — | — |
| Not listed | Milwakee | Wisconsin | — | — |
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 NCT00484991, 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 Apr 15, 2008 · Synced Oct 19, 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 public registry record, listed eligibility criteria, and available contact information for NCT00484991 live on ClinicalTrials.gov.