Nutritional Impacts of Palynziq on Patients With Phenylketonuria (PKU)
Recruiting
Observational Study
Phenylketonurias
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 16 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 45 (estimated)
- Sponsor
- Emory University · Other
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About This Trial
Phenylketonuria (PKU) is an inherited metabolic disorder that impairs the metabolism of the essential amino acid phenylalanine (Phe). Without stringent dietary control, Phe accumulates in the blood and brain of PKU patients, leading to severe cognitive deficits. Achieving metabolic control, defined as blood Phe levels within the range of 120-360 μmol/L, has been a significant challenge for PKU pat…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 16 years of age or older
* diagnosed with PKU through newborn screening or via diagnosis later in life
* capable of providing consent for medical tests and procedures
* prescription for Palynziq and be enrolled in the Palynziq Risk Evaluation and Mitigation Strategy (REMS) pro…
Contacts