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

PHASE3RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

March 6, 2023

Primary Completion Date

February 17, 2028

Study Completion Date

August 14, 2030

Conditions
Alpha1-Antitrypsin Deficiency
Interventions
DRUG

Fazirsiran Injection

Participants will receive fazirsiran 200 mg/ml SC injection on Day 1, at Week 4, and Q12 W thereafter up to Week 196.

OTHER

Placebo

Participants will receive placebo (sterile normal saline \[0.9% NaCl\]) SC injection on Day 1, at Week 4, and Q12 W thereafter up to Week 196.

Trial Locations (82)

1090

RECRUITING

Medizinische Universität Wien (Medical University of Vienna), Vienna

2650

RECRUITING

UZ Antwerpen, Antwerp

RECRUITING

Hvidovre Hospital, Hvidovre

3000

RECRUITING

UZ Leuven, Leuven

3010

RECRUITING

Inselspital Bern, Bern

3065

RECRUITING

St Vincents Hospital Melbourne - PPDS, Fitzroy

5000

WITHDRAWN

Royal Adelaide Hospital, Adelaide

6020

RECRUITING

Medizinische Universität Innsbruck, Innsbruck

8025

RECRUITING

Hospital Universitario Vall d'Hebron - PPDS, Barcelona

8036

RECRUITING

LKH-Universitätsklinikum Graz, Graz

9020

RECRUITING

Klinikum Klagenfurt Am Wörthersee, Klagenfurt

10016

RECRUITING

NYU Langone Health, New York

13353

RECRUITING

Charité - Campus Virchow-Klinikum-Ostring 1, Berlin

14186

RECRUITING

Karolinska Universitetssjukhuset Huddinge, Huddinge

17033

RECRUITING

Penn State Health Milton S. Hershey Medical Center, Hershey

20089

RECRUITING

IRCCS Istituto Clinico Humanitas, Rozzano

20122

RECRUITING

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Milan

23226

RECRUITING

Bon Secours St. Mary's Hospital, Richmond

24105

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Kiel

27100

RECRUITING

Fondazione IRCCS Policlinico San Matteo di Pavia, Pavia

29071

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

29425

RECRUITING

Medical University of South Carolina, Charleston

30329

WITHDRAWN

Children's Healthcare of Atlanta, Atlanta

30625

RECRUITING

Hannover Medical School, Hanover

31000

RECRUITING

Hospital Purpan, Toulouse

32611

RECRUITING

University of Florida, Gainesville

33064

RECRUITING

Centre Francois Magendie, Pessac

35000

RECRUITING

Hopital PONTCHAILLOU CHU de Rennes, Rennes

35233

RECRUITING

University of Alabama at Birmingham, Birmingham

39008

RECRUITING

Hospital Universitario Marques de Valdecilla, Santander

41013

RECRUITING

Hospital Universitario Virgen del Rocio - PPDS, Seville

46202

RECRUITING

Indiana University School of Medicine - Indianapolis, Indianapolis

48109

RECRUITING

University of Michigan Hospital, Ann Arbor

52074

RECRUITING

Universitätsklinikum der RWTH Aachen, Aachen

52242

RECRUITING

University of Iowa Hospitals and Clinics, Iowa City

63110

RECRUITING

Washington University School of Medicine in St. Louis, St Louis

69317

RECRUITING

Hôpital de La Croix Rousse, Lyon

72076

RECRUITING

Universitätsklinikum Tübingen, Tübingen

75020

RECRUITING

Texoma Liver Center, Denison

78215

RECRUITING

The Texas Liver Institute, San Antonio

85013

RECRUITING

St. Joseph's Hospital and Medical Center, Phoenix

92025

WITHDRAWN

Gastroenterology & Liver Institute, Escondido

92093

RECRUITING

University of California San Diego, Altman Clinical and Translational Institute, La Jolla

92110

RECRUITING

Hôpital Beaujon, Clichy

94143

RECRUITING

University of California Benioff Children's Hospital, San Francisco

94303

RECRUITING

Stanford University, Palo Alto

94805

RECRUITING

Hôpital Paul Brousse, Val-de-Marne

85054-4502

RECRUITING

Mayo Clinic, Phoenix

85724-5136

RECRUITING

University of Arizona Thomas D. Boyer Liver Institute, Tucson

90095-8344

RECRUITING

UCLA Pulmonary and Critical Care, Los Angeles

33136-1051

RECRUITING

Schiff Center for Liver Diseases/University of Miami, Miami

21201-1504

RECRUITING

University of Maryland Medical Center, Baltimore

02115

RECRUITING

Brigham and Womens Hospital, Boston

02118-2908

RECRUITING

Boston Medical Center, Boston

48377-3600

RECRUITING

Henry Ford Medical Center - Columbus, Novi

55905-0001

RECRUITING

Mayo Clinic - PPDS, Rochester

63104-1003

RECRUITING

Cardinal Glennon Children's Hospital, St Louis

10032-1559

WITHDRAWN

Morgan Stanley Childrens Hospital of New York Presbyterian (CHONY) - PIN, New York

10032-3722

RECRUITING

Columbia University Irving Medical Center, New York

44106-1716

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

19140-5103

RECRUITING

Temple University Hospital, Philadelphia

37232-0028

RECRUITING

Vanderbilt University Medical Center, Nashville

77030-4202

RECRUITING

Baylor College of Medicine Medical Center, Houston

23298-5028

RECRUITING

VCU Medical Center North Hospital, Richmond

01308-050

RECRUITING

Hospital Sirio-Libanes, São Paulo

18618-687

RECRUITING

Universidade Estadual Paulista Julio de Mesquita Filho Faculdade de Medicina Campus de Botucatu, São Paulo

V6Z 2K5

RECRUITING

GI Research Institute, Vancouver

B3H 2Y9

RECRUITING

Queen Elizabeth II Health Sciences Center, Halifax

M5T 3A9

RECRUITING

Inspiration Research Limited, Toronto

140 21

RECRUITING

Institut klinicke a experimentalni mediciny, Prague

1081 HV

RECRUITING

Amsterdam UMC - VUmc - De Boelelaan, Amsterdam

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

41-400

RECRUITING

ID Clinic Arkadiusz Pisula, Śląskie

4710-243

RECRUITING

CCA Hospital Braga, Braga

9000-168

RECRUITING

Hospital Nélio Mendonça, Funchal

4099-003

RECRUITING

Centro Hospitalar do Porto, Porto

581 85

RECRUITING

Universitetssjukhuset i Linköping, Linköping

EH16 4SA

RECRUITING

Royal Infirmary of Edinburgh, Edinburgh

NW3 2Q

RECRUITING

Royal Free Hospital, London

SE5 9RS

RECRUITING

King's College Hospital, London

NG7 2UH

WITHDRAWN

Queen's Medical Centre, Nottingham

PL6 8DH

RECRUITING

Derriford Hospital, Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Takeda Development Center Americas, Inc.

INDUSTRY

lead

Takeda

INDUSTRY