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Completed No phase listed Observational

PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry

ClinicalTrials.gov ID: NCT00778206

Public ClinicalTrials.gov record NCT00778206. 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.

ClinicalTrials.gov public records Last synced Oct 23, 2026, 9:05 AM EDT

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 objective of this study is to evaluate the safety of long-term treatment with Kuvan.

Study identification

NCT ID
NCT00778206
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
BioMarin Pharmaceutical
Industry
Enrollment
1,887 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
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 2008 (Type not available)
Primary completion
Jan 29, 2021 (Actual)
Completion
Jan 29, 2021 (Actual)
Last update posted
Oct 12, 2022

2008 – 2021

United States locations

U.S. sites
45
U.S. states
29
U.S. cities
41
Facility City State ZIP Site status
Childrens Hospital of Los Angeles Los Angeles California 90027 —
LAC and USC Medical Center Los Angeles California 90033 —
UCLA Los Angeles California 90095 —
Children's Hospital of Orange County Orange California 92868 —
University of California, San Diego San Diego California 92093 —
Stanford University, Pediatrics Stanford California 94305 —
Children's Hospital, University of Colorado School of Medicine Aurora Colorado 80045 —
Children's National Medical Center Washington D.C. District of Columbia 20010 —
University of Florida Gainesville Florida 32611 —
University of Miami, Miller School of Medicine, Department of Human Genetics Miami Florida 33136 —
University of South Florida Tampa Florida 33606 —
Tampa Children's Hospital, St. Joseph's Pediatric Endocrine Associates Tampa Florida 33607 —
Emory University Decatur Georgia 30033 —
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois 60611 —
Indiana University School of Medicine Indianapolis Indiana 46202 —
University of Iowa Iowa City Iowa 52242 —
Wesley Pediatric Faculty Clinic Wichita Kansas 67208 —
University of Kentucky Lexington Kentucky 40536 —
Kosair Charities Pediatric Clinical Research Unit Louisville Kentucky 40202 —
Tulane University Medical School New Orleans Louisiana 70112 —
Johns Hopkins University School of Medicine Baltimore Maryland 21287 —
Children's Hosptial of Boston Boston Massachusetts 02115 —
University of Minnesota Minneapolis Minnesota 55455 —
University of Missouri Health Care Columbia Missouri 65212 —
St. Louis Children's Hospital St Louis Missouri 63110 —
University of Nebraska Omaha Nebraska 68182 —
AHS Hospital Corp Morristown New Jersey 07960 —
Albany Medical Center Albany New York 12208 —
University of Rochester Medical Center Rochester New York 14642 —
Westchester Medical Center Valhalla New York 10595 —
University of North Carolina Chapel Hill North Carolina 27599 —
Akron Children's Hospital Akron Ohio 44308 —
Nationwide Children's Hospital Columbus Ohio 43205 —
University of Oklahoma Oklahoma City Oklahoma 73104 —
Oregon Health and Science University Portland Oregon 97239 —
Penn State, Milton S. Hershey Medical Center Hershey Pennsylvania 17033 —
Children's Hospital of Philadelphia Philadelphia Pennsylvania 19104 —
St. Christophers Hospital for Children Philadelphia Pennsylvania 19134 —
Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224 —
Greenwood Genetic Center Greenwood South Carolina 29646 —
Sanford Children's Specialty Clinic Sioux Falls South Dakota 57117 —
University of Utah Salt Lake City Utah 84132 —
Children's Hospital of the King's Daughters Norfolk Virginia 23507 —
West Virginia Genetics Center, Department of Pediatrics Morgantown West Virginia 26506 —
Children's Hospital of Wisconsin Milwaukee Wisconsin 53226 —

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 NCT00778206, 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 Oct 12, 2022 · Synced Oct 23, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00778206 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →