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A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)

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Trial Status Recruiting

Trial Identifier

NCT06305234

Condition

Phenylketonuria, Phenylketonuria (PKU)

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

This is a 10-year multi-center, prospective, longitudinal, single arm study evaluating immunologic, inflammatory and laboratory parameters associated with long-term Palynziq treatment in subjects with phenylketonuria (PKU) in the United States (US). Subjects in the US for whom a clinical decision has been made that they will receive pegvaliase to treat their PKU within 30 days following the date of enrollment in Study 165-501 (incident-users) or who have previously started treatment with pegvaliase at the date of enrollment in Study 165-501 (prevalent-users) are eligible for participation in Study 165-503.

Eligibility Criteria

Birth Sex

All

Age

Any

Healthy Volunteers

No

Drug/Treatment:

Pegvaliase

Study Type:

Observational

Number of Participants:

200

Study Started:

2024-01-20

Study Updated:

2024-08-26

Trial Locations

  • University of Colorado

    Aurora, Colorado, United States

  • Northwestern University

    Chicago, Illinois, United States

  • Tulane University School of Medicine

    New Orleans, Louisiana, United States

  • Oregon Health & Science University

    Portland, Oregon, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, United States

  • UT Southwestern Medical Center

    Dallas, Texas, United States

Inclusion Criteria

  • Subjects enrolled at US sites participating in the 165-501 study.

Exclusion Criteria

  • Legal incapacity or limited legal capacity without legal guardian representation.
  • Subject is unable or unwilling to provide informed consent for the additional interventional burden of the study (blood sampling)

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