APPROVED_FOR_MARKETINGNot Applicable

Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria

Plain-language summary

The purpose of this study is to provide expanded access of givosiran to patients with Acute Hepatic Porphyria (AHP).

Age range12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. Alanine aminotransferase (ALT) \>2×ULN
✕. Total bilirubin \>1.5×ULN. Patients with elevated total bilirubin that is secondary to documented Gilbert's syndrome are eligible if the total bilirubin is \<2×ULN
✕. Estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73 m2

NCT IDNCT04056481

SponsorAlnylam Pharmaceuticals

Sponsor typeINDUSTRY

Study typeEXPANDED_ACCESS