An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease (NCT05899673)
A Phase 3, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Fazirsiran in Participants With Alpha-1 Antitrypsin Deficiency-Associated Liver Disease
🩺 Plain-English Summary (8th-Grade Level)
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 have taken part in previous fazirsiran studies (AROAAT2001 \[NCT03945292\] or AROAAT2002 \[NCT03946449\]) can continue to receive fazirsiran every 3 months as long as they participate in this study, the study is ongoing or until health authorities in their country approve fazirsiran to be publicly available. 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.
Who can join: Review the eligibility criteria below.
Location: UCSD Altman Clinical and Translational Research Institute — La Jolla, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- UCSD Altman Clinical and Translational Research Institute — La Jolla, California
- Stanford Medicine Outpatient Center — Redwood City, California
- UF Clinical and Translational Science Institute — Gainesville, Florida
- University Of Iowa Hospitals And Clinics — Iowa City, Iowa
- Medical University of South Carolina - Hollings Cancer Center - PPDS — Charleston, South Carolina
- Medizinische Universitat Wien (Medical University of Vienna) — Vienna,
- Universitätsklinikum der RWTH Aachen — Aachen, North Rhine-Westphalia
- Hospital Nélio Mendonça — Funchal,
- Addenbrooke's Hospital — Cambridge,
- Royal Infirmary of Edinburgh - PPDS — Edinburgh,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Alpha1-Antitrypsin Deficiency
- A Study in Adults to Learn About Inherited Alpha-1 Antitrypsin Deficiency (AATD) and AATD Related Liver Problems — Gainesville, Florida
- Study to Learn About the Safety of Fazirsiran and if it Can Help People With Alpha-1 Antitrypsin Liver Disease With Mild Liver Scarring (Fibrosis) — Phoenix, Arizona
- Study to Check the Safety of Fazirsiran and Learn if Fazirsiran Can Help People With Liver Disease and Scarring (Fibrosis) Due to an Abnormal Version of Alpha-1 Antitrypsin Protein — Birmingham, Alabama
Explore by condition: All Alpha1-Antitrypsin Deficiency clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.