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

Completed · Phase 1/Phase 2

Conditions studied: Acute Intermittent Porphyria

In brief

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).

Key facts

Study ID

NCT02949830

Run by

Alnylam Pharmaceuticals

People needed

16

Starts

2016-10-01

Expected to finish

2021-11-05

Last updated by the study team

2024-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Clinical Trial Site — San Francisco, California, United States
• Clinical Trial Site — New York, New York, United States
• Clinical Trial Site — Galveston, Texas, United States
• Clinical Trial Site — Stockholm, Sweden
• Clinical Trial Site — London, United Kingdom

Full record on ClinicalTrials.gov

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