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ACTIVE NOT RECRUITING
NCT05899673
PHASE3

An Extension Study to Learn About the Long-Term Safety of Fazirsiran and if Fazirsiran Can Help People With Alpha-1 Antitrypsin Liver Disease

Sponsor: Takeda

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2023-08-08

Completion Date

2033-05-02

Last Updated

2025-10-14

Healthy Volunteers

No

Interventions

DRUG

Fazirsiran Injection

Fazirsiran will be injected subcutaneously.

Locations (10)

UCSD Altman Clinical and Translational Research Institute

La Jolla, California, United States

Stanford Medicine Outpatient Center

Redwood City, California, United States

UF Clinical and Translational Science Institute

Gainesville, Florida, United States

University Of Iowa Hospitals And Clinics

Iowa City, Iowa, United States

Medical University of South Carolina - Hollings Cancer Center - PPDS

Charleston, South Carolina, United States

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, Austria

Universitätsklinikum der RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Hospital Nélio Mendonça

Funchal, Portugal

Addenbrooke's Hospital

Cambridge, United Kingdom

Royal Infirmary of Edinburgh - PPDS

Edinburgh, United Kingdom