An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease
About this clinical trial
The main aim of this study is to learn if fazirsiran is safe during long-term use in people with liver disease caused by the abnormal Z-alpha-1 antitrypsin (Z-AAT) protein. People who are currently taking part in or have completed previous fazirsiran studies (AROAAT2001 [NCT03945292] or AROAAT2002 [NCT03946449]) can continue to receive fazirsiran in this study. Participants will receive fazirsiran every 3 months for almost 2 years and will then be followed for an additional 6 months. The study may also provide information on whether fazirsiran has a long-term effect in reducing liver fibrosis or slowing down the progression of liver fibrosis in people with liver disease due to the abnormal Z-AAT protein.
At a glance
What medical conditions were being studied?
What was the clinical trial testing?
Fazirsiran Injection
How many participants were enrolled?
37
Were placebos part of the clinical trial?
No
When was the clinical trial conducted?
Aug 2023 - May 2026
How long was participation in the clinical trial?
Participants will stay in the study for up to 120 weeks (approximately 2.5 years) and will receive treatment for up to 96 weeks (approximately 2 years).
Key requirements
Sexes
All
Age
18+ Years
Healthy volunteers?
No
Entry criteria
