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A Prospective Clinical Study of Phenylketonuria (PKU)

NCT04452513·14 sites·ClinicalTrials.gov

What this study is about

Take this into the appointment.

Saves the questions and what to expect into your notes, next to the visit they belong to.

Keep this study

Lead

BioMarin Pharmaceutical

Age

14–any

Sex

ALL

Healthy volunteers

Not accepted

You may be eligible if

Male and female subjects with diagnosis of PKU which is a condition characterized by PAH deficiency
Ability and willingness to maintain dietary protein intake consistent with baseline intake
Willingness and capable per investigator opinion to comply with study procedures and requirements
Plasma Phe Levels \> 600umol/L

You may not be if

Clinically significant liver dysfunction or disease
Prior treatment with gene therapy
Any condition that, in the opinion of the investigator or Sponsor, would prevent the subject from fully complying with the requirements of the study

The record

StatusCompleted

PhaseNo phase

Taking part32

StartedOct 2019

UpdatedMar 14, 2023

Conditions

Phenylketonurias

Where14

Children's Hosptial of Colorado
Aurora, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of South Florida
Tampa, Florida, United States

Clareo Health | A Prospective Clinical Study of Phenylketonuria (PKU)