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NCT06305234 · ClinicalTrials.gov registry record
A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)
A clinical trial of Phenylketonuria (PKU), sponsored by BioMarin Pharmaceutical.
- Recruiting
- Registry status
- 200
- Enrollment target
- 6
- Study locations
NCT06305234: Recruiting study of Phenylketonuria (PKU), sponsored by BioMarin Pharmaceutical.
NCT06305234 is a study of Phenylketonuria (PKU) that is actively recruiting participants, run by BioMarin Pharmaceutical. The registered enrollment target is 200 participants, above the 149-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (34% higher). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06305234, a study of Phenylketonuria (PKU), is actively recruiting participants, sponsored by BioMarin Pharmaceutical.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 6
- Study locations
Study 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.
Primary Outcome
* Acute systemic hypersensitivity reaction * Anaphylaxis * Angioedema * Serum sickness * Severe hypersensitivity reaction * Severe or Persistent arthralgia * Severe injection site reaction
Conditions Studied
Interventions
- DRUG Pegvaliase
Study Locations (6)
Colorado
- University of Colorado - Aurora
Illinois
- Northwestern University - Chicago
Louisiana
- Tulane University School of Medicine - New Orleans
Oregon
- Oregon Health & Science University - Portland
Pennsylvania
- University of Pittsburgh Medical Center - Pittsburgh
Texas
- UT Southwestern Medical Center - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-01-20 |
| Est. Completion | 2033-11-18 |
What NCT06305234 shows while recruiting
NCT06305234 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 149-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (34% higher).
The record links to 1 condition, with Phenylketonuria (PKU) appearing as the primary indexed condition, and to 1 intervention - of which Pegvaliase is the first listed.
NCT06305234 lists 6 locations in 6 states (Colorado, Illinois, Louisiana).
Frequently Asked Questions
What is clinical trial NCT06305234 about?
NCT06305234 is a clinical study titled "A Long Term, Post-marketing Study of Immune Response in Patients Receiving Palynziq Treatment for PKU (PALisade)". 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 ha...
What is the current status of trial NCT06305234?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2024-01-20. Estimated completion is 2033-11-18.
What conditions does trial NCT06305234 study?
This clinical trial studies the following conditions: Phenylketonuria (PKU).
What interventions are being tested in trial NCT06305234?
The interventions under investigation include: Pegvaliase (DRUG).
Who is sponsoring clinical trial NCT06305234?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06305234 being conducted?
This trial has 6 study locations across Colorado, Illinois, Louisiana, Oregon, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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