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) (NCT06165341)
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Fazirsiran in the Treatment of Alpha-1 Antitrypsin Deficiency-Associated Liver Disease With METAVIR Stage F1 Fibrosis
🩺 Plain-English Summary (8th-Grade Level)
The liver produces a protein called alpha-1 antitrypsin (AAT). AAT is normally released into the bloodstream. In some people, the liver makes an abnormal version of the AAT protein, called Z-AAT. Making an abnormal version of the AAT protein can result in liver disease as Z-AAT builds up in liver cells, which leads to liver problems such as liver scarring (fibrosis), continuing liver damage (cirrhosis), and eventually end stage liver disease. Fazirsiran is a medicine that reduces the creation of the Z-AAT protein and thus the build-up of this abnormal protein in the liver. People with this type of liver disease who already have mild liver scarring will take part in the study. They will be treated with fazirsiran or a placebo for about 2 years. This study will check the long-term safety of fazirsiran, whether participants tolerate the treatment and if there are any effects on liver scarring. A liver biopsy, a way of collecting a small tissue sample from the liver, will be taken twice during the study.
Who can join: Review the eligibility criteria below.
Location: St Joseph's Hospital and Medical Center — Phoenix, Arizona
Age range: 18 Years to 75 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 (41 Sites)
Showing the first 25 of 41 sites.
- St Joseph's Hospital and Medical Center — Phoenix, Arizona
- Mayo Clinic - PPDS — Phoenix, Arizona
- University of Arizona Thomas D. Boyer Liver Institute — Tucson, Arizona
- University of California San Diego — La Jolla, California
- UCLA Pulmonary and Critical Care — Los Angeles, California
- University of California Benioff Children's Hospital — San Francisco, California
- Peak Gastroenterology Associates — Colorado Springs, Colorado
- Schiff Center for Liver Diseases/University of Miami — Miami, Florida
- Indiana University School of Medicine-Indianapolis — Indianapolis, Indiana
- University Of Iowa Hospitals And Clinics — Iowa City, Iowa
- Boston Medical Center — Boston, Massachusetts
- University of Michigan Hospital - 1500 E Medical Center Dr — Ann Arbor, Michigan
- Henry Ford Health System — Novi, Michigan
- Mayo Clinic PPDS — Rochester, Minnesota
- NYU Langone Medical Center — New York, New York
- Columbia University Irving Medical Center — New York, New York
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania
- Texas Liver Institute American Research Corporation — San Antonio, Texas
- Bon Secours St. Mary's Hospital — Newport, Virginia
- LKH-Universitätsklinikum Graz — Graz,
- KABEG - Klinikum Klagenfurt Am Wörthersee — Klagenfurt,
- UZ Antwerpen — Antwerp,
- UZ Leuven — Leuven,
- Inspiration Research Limited — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (877) 825-3327
Email: medinfoUS@takeda.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease — La Jolla, California
- A Study in Adults to Learn About Inherited Alpha-1 Antitrypsin Deficiency (AATD) and AATD Related Liver Problems — Gainesville, Florida
- 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.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.