Status:
COMPLETED
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response
Lead Sponsor:
University of Miami
Conditions:
Phenylketonuria
Eligibility:
All Genders
4+ years
Phase:
PHASE2
Brief Summary
The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet. Lowering ...
Eligibility Criteria
Inclusion
- all patients with a diagnosis of phenylketonuria
- patients who are over the age of 4 years,
- patients with a fasting blood phenylalanine ≥600µmol/l
Exclusion
- female patients who are pregnant or attempting to become pregnant
- children under four years of age
- Concurrent disease of condition that would interfere with study participation or safety such as history of neurological compromise or major medical, psychiatric or learning disorder unrelated to PKU
- Any condition that, in the view of the Investigators, places subject at high risk of poor treatment compliance or of not completing the study
- Use of L-Dopa, methotrexate, or other drugs that may inhibit folate metabolism
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2011
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00841100
Start Date
December 1 2008
End Date
July 19 2011
Last Update
December 3 2019
Active Locations (1)
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1
Department of Biochemistry & Molecular Biology
Miami, Florida, United States, 33136