Retrospective Observational Safety Effectiveness With Kuvan in hpA
NCT03864029 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 26
Last updated 2019-03-07
Summary
A retrospective study to collect the effectiveness and safety data of the past treatment with KUVAN in Chinese patients with HPA caused by BH4 deficiency. The data was collected from relevant past medical history and past clinical and safety assessments.
Conditions
- Tetrahydrobiopterin Deficiency
Interventions
- DRUG
-
KUVAN
retrospective data on the effectiveness of past treatment with KUVAN®. It includes blood Phe level, physical development status, intelligence development status, etc., during treatment with KUVAN
Sponsors & Collaborators
-
Quintiles, Inc.
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Medical Director, MD · Medical Director
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-10-10
- Primary Completion
- 2018-03-09
- Completion
- 2018-07-25
- FDA Drug
- Yes
Countries
- China
Study Locations
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