PKUDOS: Phenylketonuria (PKU) Demographic, Outcomes, and Safety Registry
NCT00778206 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1887
Last updated 2022-10-12
Summary
The objective of this study is to evaluate the safety of long-term treatment with Kuvan.
Conditions
- Phenylketonuria
- Hyperphenylalaninaemia
Interventions
- DRUG
-
Kuvan
-Recommended post-partum Assessments include: collection of baby's plasma at Birth, 1 Month and 6 months, and collection of mother's plasma and expressed breast milk sample at 1 Month.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Kristin Lindstrom, MD · BioMarin Pharmaceutical
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-09-30
- Primary Completion
- 2021-01-29
- Completion
- 2021-01-29
Countries
- United States
Study Locations
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