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NCT00924703 · ClinicalTrials.gov registry record · Phase 2

Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)

A Phase 2 study, sponsored by BioMarin Pharmaceutical.

Completed
Registry status
Phase 2
Development phase
68
Enrollment target

NCT00924703: Completed Phase 2 study, sponsored by BioMarin Pharmaceutical.

NCT00924703 is a Phase 2 study that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 68 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00924703, a Phase 2 study, has completed, sponsored by BioMarin Pharmaceutical.

COMPLETED
Registry status
Phase 2
Development phase
68 participants
Enrollment target

Study Summary

This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain reduced blood Phe concentrations in PKU subjects.

Primary Outcome

Blood Phe Concentration (Change from Baseline) and Daily Dose in PAL-003 Subjects by Disposition (PAL-003 Population)

Interventions

  • DRUG rAvPAL-PEG

Trial Details

FieldValue
Enrollment Target 68 participants
Start Date 2010-01-13
Est. Completion 2019-01-31
Phase Phase 2
BioMarin Pharmaceutical

80 total trials

What the finished NCT00924703 record still lists

NCT00924703 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 68 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (49% lower).

The record links to 0 conditions, and to 1 intervention - of which rAvPAL-PEG is the first listed.

NCT00924703 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00924703 about?

NCT00924703 is a clinical study titled "Long-Term Extension of Previous rAvPAL-PEG Protocols in Subjects With PKU (PAL-003)". This study is an extension of previous rAvPAL-PEG studies. Administration of rAvPAL-PEG will be continued to assess whether long-term dosing of rAvPAL-PEG is safe and can maintain reduced blood Phe concentrations in PKU subjects.

What is the current status of trial NCT00924703?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2010-01-13. Estimated completion is 2019-01-31.

What interventions are being tested in trial NCT00924703?

The interventions under investigation include: rAvPAL-PEG (DRUG).

Who is sponsoring clinical trial NCT00924703?

This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00924703's enrollment target sits among peer trials

68 967th of 2000 higher than 1,027 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00924703, the US trial registry maintained by the National Library of Medicine. NCT00924703 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.