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

NCT00778206 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1887

Last updated 2022-10-12

No results posted yet for this study

Summary

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

Conditions

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00778206 on ClinicalTrials.gov