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A Long-term, Post-marketing Safety Study of Palynziq in Patients With PKU (PALace)

Studying Palynziq's long-term safety for PKU patients.

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  • Technical description (Original)

Study Overview: This study checks the long-term safety of a drug called pegvaliase for treating PKU, a condition where people can't break down the amino acid phenylalanine (Phe) properly. The study lasts 10 years and looks at any allergic reactions or other safety concerns.

What to Expect: If you join, your doctor will share your medical history and any reactions you have to the drug. There are no extra visits or tests required. Your doctor will see you as usual, checking on your health as part of regular care.

  • The study lasts for 10 years.
  • No extra doctor visits or tests are needed.
  • No new treatments are being tested during this study.
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Study details
    Phenylketonuria (PKU)

NCT05813678

BioMarin Pharmaceutical

25 April 2026

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What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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