Back to Results

Nutrition Status of Adults With PKU Before and During Treatment With Pegvaliase

Interested in this Trial?

Contact Us

Trial Status Completed

Trial Identifier

NCT03856203

Condition

Phenylketonuria, Phenylketonurias

The below information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. and has not been edited.

Trial Summary

Conduct a prospective, longitudinal study to evaluate nutritional status in adults with phenylketonuria (PKU) before and during treatment with pegvaliase (Palynziq™).

Eligibility Criteria

Birth Sex

All

Age

18 Years to 65 Years

Healthy Volunteers

No

Study Type:

Observational

Number of Participants:

12

Study Started:

2019-03-08

Study Updated:

2023-11-18

Trial Locations

  • Boston Children's Hospital

    Boston, Massachusetts, United States

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 lactatin

Contact BioMarin Clinical Trials

Please complete and submit the following form to express interest in participating and request more information about one of our active clinical trials

*required fields

"*" indicates required fields

Please select the trial that you are interested in from the dropdown below. Note that this list only includes currently active trials. If you cannot find the trial you are seeking, please enter the study identifier and title in the comments box below, along with any other details you would like us to know to help address your inquiry.
Consent*
Consent*
For more Information about BioMarin's privacy obligations or to exercise your privacy rights, please visit BioMarin's Data Privacy Center.
This field is hidden when viewing the form
This field is hidden when viewing the form
This field is hidden when viewing the form
This field is hidden when viewing the form

What’s Next?

Visit the following links to learn more about clinical trials.

Discuss this trial with your care team.

You may wish to print this page to share the details with your healthcare providers and discuss whether you may be eligible.

Print

Get in touch.

Contact Us