A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)

A Multicenter, Open-label Extension Study to Evaluate the Long-term Safety and Clinical Activity of Subcutaneously Administered ALN-AS1 in Patients With Acute Intermittent Porphyria Who Have Completed a Previous Clinical Study With ALN-AS1

The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).

Inclusion Criteria:

• Completed participation in Part C of study ALN-AS1-001 (NCT02452372)
• Not on a scheduled regimen of hemin
• Women of child bearing potential must have a negative serum pregnancy test, not be nursing, and use acceptable contraception
• Willing and able to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

• Clinically significant abnormal laboratory results
• Received an investigational agent (other than ALN-AS1) within 90 days before the first dose of study drug or are in follow-up of another clinical study
• History of multiple drug allergies or intolerance to subcutaneous injection