Efficacy and Safety of Alpha1-Proteinase Inhibitor (Human), Modified Process (Alpha-1 MP) in Subjects With Pulmonary Emphysema Due to Alpha1 Antitrypsin Deficiency (AATD)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

345

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

August 31, 2026

Study Completion Date

January 31, 2027

Conditions
Pulmonary Emphysema in Alpha-1 PI Deficiency
Interventions
BIOLOGICAL

Alpha-1 MP

OTHER

0.9% Sodium Chloride for Injection, USP

Trial Locations (52)

1051

New Zealand Respiratory and Sleep institute, Auckland

2010

St Vincent's Hospital Sydney, Sydney

2025

"Institutul de Ftiziopneumologie Chiril Draganiuc", Chisinau

2900

Gentofte Hospital, Hellerup

3065

St Vincent's Hospital Melbourne, Fitzroy

3240

Waikato Hospital, Hamilton

4032

The Prince Charles Hospital, Chermside

5000

Centro Dr. Lazaro Langer, Córdoba

Royal Adelaide Hospital, Adelaide

6009

Institute for Respiratory Health Inc, Nedlands

8000

Århus Universitetshospital, Arhus C

8013

Christchurch Hospital NZ, Christchurch

11361

Karolinska Universitetssjukhuset, Solna, Stockholm

13419

North Estonia Medical Centre Foundation, Tallinn

17033

Penn State Univ. Milton S. Hershey Medical Center, Hershey

20502

Skånes Universitetssjukhus, Malmö, Malmo

20520

Turku University Central Hospital, Department of Pulmonary Diseases, Turku

28401

Accellacare, Wilmington

29425

Medical University of South Carolina, Charleston

32610

University of Florida, Gainesville

33011

Hospital Universitario Central de Asturias, Oviedo

33136

University of Miami Miller School of Medicine, Miami

33604

Groupe Hospitalier Sud - Hôpital Haut-Lévêque, Pessac

34748

Medical Research of Central Florida, LLC, Leesburg

35043

Universitaetsklinikum Giessen und Marburg GmbH, Marburg

41345

Sahlgrenska Sjukhuset, Gothenburg

45239

Ruhrlandklinik, Essen

48903

Hospital de Cruces, Barakaldo

51014

Tartu University Hospital, Tartu

63110

Washington University School of Medicine, St Louis

66421

Univer des Saarlandes Innere, Homburg Saar

69126

Universitaetsklinikum Heidelberg, Heidelberg

69500

Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Bron

75708

University of Texas Health Center at Tyler, Tyler

85013

St. Joseph's Hospital and Medical Center, Phoenix

97239

Oregon Health & Science University, Portland

105077

FSI Scientific Research Institute of Pulmonology, Moscow

150003

"SAIH of Yaroslavl region Clinical Hospital of Emergency Medical Care n.a. N. V. Solovyev", Yaroslavl

300312

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie, Timișoara

410176

Clinic Dr.G Curteanu Oradea, Oradea

656038

SBEI HPE Altai State Medical University of MoH and SD, Barnaul

B1602DOH

Hospital del Torax Dr. Antonio A. Cetrangolo, Vicente López

09060-650

Faculdade de Medicina do ABC, Santo André

04023-061

UNIFESP - Universidade Federal de São Paulo, São Paulo

05403-000

Instituto do Coração - Incor- HCFMUSP, São Paulo

A1B 3V6

Health Sciences Centre, St. John's

B3H3A8

Queen Elizabeth II Health Sciences Centre, Halifax

M5T3A11

Inspiration Research Limited, Toronto

31-066

SPZOZ Szpital Uniwersytecki w Krakowie, Krakow

01-138

Instytut Gruzlicy i Chorob Pluc w Warszawie, Warsaw

587 58

CTC - Clinical Trial Consultants AB, Linköping

752 37

CTC Clinical Trial Consultants AB, Uppsala

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY