Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
18 participants
OBSERVATIONAL
2019-01-17
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Pegvaliase
Treated with pegvaliase for one or more years or followed an unrestricted diet for 6 or more months while being treated with pegvaliase.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Aged 18-65 years
3. Currently treated with pegvaliase
4. Have either 1) received treatment with pegvaliase for one or more years or 2) followed an unrestricted diet for 6 or more months while on pegvaliase
5. Currently following an unrestricted diet that meets or exceeds the RDA for protein (0.8 g/kg/day)
Exclusion Criteria
2. Under age 18 years or over age 65
3. Routine food intake provides less than the RDA for protein (0.8 g/kg/d)
4. Consuming any PKU medical foods
18 Years
65 Years
ALL
No
Sponsors
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BioMarin Pharmaceutical
INDUSTRY
Boston Children's Hospital
OTHER
Responsible Party
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Krista Viau
Clinical Nutrition Specialist II
Principal Investigators
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Krista Viau, PhD, RD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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P00029611
Identifier Type: -
Identifier Source: org_study_id
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