Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-24 @ 7:36 PM
NCT ID:
NCT03856203
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of phenylketonuria
* Aged 18-65 years
* Following a protein-restricted diet with or without medical food within the last 30 days
* Routine natural protein intake from food is less than the RDA for protein based on weight (0.8 g/kg/day).
* If not consuming animal proteins, recommended protein intake is 115% RDA due to lower bioavailability of plant proteins.
* Within ±90 days of starting treatment with pegvaliase at time of study enrollment
Exclusion Criteria:
* Unable to consent to study
* Under age 18 or over age 65 years
* Routine natural protein intake is greater than the RDA for protein (0.8 g/kg/d) within the last 30 days.
* Females who are currently pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03856203
Study Brief:
Protocol Section:
NCT03856203