This study is currently not recruiting participants.

An Open-label Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Injections of Pegvaliase (> 40 mg/day Dose) in Adults with Phenylketonuria

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Updated on 19 February 2024

Summary

PALYNZIQ was approved by the United States FDA in May 2018 for daily doses up to 40 mg after dose escalation as directed by the prescribing healthcare provider experienced in the management of PKU. Pegvaliase has not been approved as safe and effective by the FDA at doses above 40 mg/day. This study will help learn more about whether the study drug at doses above 40 mg/day is safe and whether it works in lowering levels of Phe that is in blood.

Description

PALYNZIQ was approved by the United States FDA in May 2018 for daily doses up to 40 mg after dose escalation as directed by the prescribing healthcare provider experienced in the management of PKU. Pegvaliase has not been approved as safe and effective by the FDA at doses above 40 mg/day. This study will help learn more about whether the study drug at doses above 40 mg/day is safe and whether it works in lowering levels of Phe that is in blood.

Details
Condition phenylketonuria
Age 100years or below
Clinical Study IdentifierTX9291
Last Modified on19 February 2024

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