Expanded Access Protocol of Givosiran for Patients With Acute Hepatic Porphyria (AHP)

ALN-AS1-005

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

-1

Inclusion Criteria: * Diagnosed with Acute Hepatic Porphyria (Acute Intermittent Porphyria, Hereditary Coproporhyria, Variegate Porphyria, ALA dehydratase deficient porphyria) * Have adequate venous access for program sample collections as judged by the Investigator for study sample collections Exclusion Criteria: * Previously or currently participating in a givosiran clinical trial * Has any of the following laboratory parameter assessments at Screening: 1. Alanine aminotransferase (ALT) \>2×ULN 2. 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 3. Estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73 m2 * On an active liver transplantation waiting list

{'studyType': 'EXPANDED_ACCESS', 'nPtrsToThisExpAccNctId': 1, 'expandedAccessTypes': {'treatment': True}}

2024-05-20