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Completed Phase 1 Interventional

Safety and Tolerability Study of rAvPAL-PEG to Treat Phenylketonuria

ClinicalTrials.gov ID: NCT00634660

Public ClinicalTrials.gov record NCT00634660. 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 Sep 2, 2026, 1:08 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single, Subcutaneous Doses of rAvPAL-PEG in Subjects With Phenylketonuria

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety and tolerability of injections of rAvPAL-PEG in subjects with PKU.

Study identification

NCT ID
NCT00634660
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
BioMarin Pharmaceutical
Industry
Enrollment
25 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
16 Years to 50 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
Apr 30, 2008
Primary completion
Mar 31, 2009
Completion
Sep 30, 2009
Last update posted
Jan 31, 2017

2008 – 2009

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
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
Mount Sinai Medical Center New York New York 10029
Oregon Health & Science University Portland Oregon 97239
University of Pittsburgh Pittsburgh Pennsylvania 15213
University of Utah Hospital Salt Lake City Utah 84132
University of Wisconsin Madison Wisconsin 53705

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 NCT00634660, 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 Jan 31, 2017 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00634660 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →