{"id":2670,"date":"2022-09-02T11:47:53","date_gmt":"2022-09-02T11:47:53","guid":{"rendered":"https:\/\/palynziqhcp-dev-001.azurewebsites.net\/en-us\/palynziq\/?page_id=2670"},"modified":"2024-06-12T13:36:24","modified_gmt":"2024-06-12T13:36:24","slug":"clinical-trial-design","status":"publish","type":"page","link":"https:\/\/hcp.biomarin.com\/en-us\/palynziq\/clinical-trial-design\/","title":{"rendered":"Clinical Trial design"},"content":{"rendered":"
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Clinical Trial Design\n<\/h1>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n\n
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The largest clinical trial program ever conducted in adult patients with PKU1<\/sup><\/h2>\n

More than 350 patients over 10 years participated in the extensive clinical trial program that established efficacy, safety, and dosing regimen of PALYNZIQ\u00ae<\/sup> (pegvaliase-pqpz) Injection.1,2<\/sup><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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\n\t\t\t \"PRISM-1\t\t\t<\/div>\n\t\t\t
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*Patients were randomized 2:1 to either continue their randomized dosage of PALYNZIQ (20 mg or 40 mg once daily) or receive matching placebo.<\/small><\/p>\n<\/figcaption>\n <\/figure>\n <\/div>\n <\/div>\n<\/div>\n\n

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Patient characteristics at baseline<\/h2>\n

Baseline patient demographics included patients with significantly elevated blood Phe levels >1200 \u00b5mol\/L (20 mg\/dL).3<\/sup><\/p>\n <\/div>\n <\/div>\n <\/div>\n<\/div>\n\n

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The majority of patients were not on a Phe-restricted diet* prior to and during the PRISM studies.3<\/sup><\/h4>\n