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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06305234
The ClinicalTrials.gov registry entry for NCT06305234 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 149-participant average among 6 other Phenylketonuria (PKU) trials with a reported enrollment target (34% higher). The listed sponsor is BioMarin Pharmaceutical, which has 80 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.