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RECRUITING
NCT06165341
PHASE3

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)

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-03-01

Completion Date

2028-08-26

Last Updated

2026-03-05

Healthy Volunteers

No

Interventions

DRUG

Fazirsiran Injection

Fazirsiran will be injected subcutaneously.

DRUG

Placebo

Fazirsiran matching placebo.

Locations (41)

St Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Mayo Clinic - PPDS

Phoenix, Arizona, United States

University of Arizona Thomas D. Boyer Liver Institute

Tucson, Arizona, United States

University of California San Diego

La Jolla, California, United States

UCLA Pulmonary and Critical Care

Los Angeles, California, United States

University of California Benioff Children's Hospital

San Francisco, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States

Indiana University School of Medicine-Indianapolis

Indianapolis, Indiana, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Boston Medical Center

Boston, Massachusetts, United States

University of Michigan Hospital - 1500 E Medical Center Dr

Ann Arbor, Michigan, United States

Henry Ford Health System

Novi, Michigan, United States

Mayo Clinic PPDS

Rochester, Minnesota, United States

NYU Langone Medical Center

New York, New York, United States

Columbia University Irving Medical Center

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Texas Liver Institute American Research Corporation

San Antonio, Texas, United States

Bon Secours St. Mary's Hospital

Newport, Virginia, United States

LKH-Universitätsklinikum Graz

Graz, Austria

KABEG - Klinikum Klagenfurt Am Wörthersee

Klagenfurt, Austria

UZ Antwerpen

Antwerp, Belgium

UZ Leuven

Leuven, Belgium

Inspiration Research Limited

Toronto, Ontario, Canada

Hôpital de La Croix Rousse

Lyon, France

Hopital PONTCHAILLOU CHU de Rennes

Rennes, France

Hôpital Paul Brousse

Val-de-Marne, France

Universitätsklinikum der RWTH Aachen

Aachen, Germany

Charité - Campus Virchow-Klinikum

Berlin, Germany

Hannover Medical School

Hanover, Germany

Universitätsklinikum Tübingen

Tübingen, Germany

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

ID Clinic Arkadiusz Pisula

Mysłowice, Poland

CCA Hospital Braga

Braga, Portugal

Hospital Dr. Nélio Mendonça

Funchal, Portugal

Centro Hospitalar de Universitário de Santo António E.P.E

Porto, Portugal

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Karolinska Universitetssjukhuset Huddinge

Huddinge, Sweden

Universitätsspital Bern

Bern, Switzerland

King's College Hospital

London, United Kingdom