Long Term Safety of Alpha1-Proteinase Inhibitor in Subjects With Alpha1 Antitrypsin Deficiency

PHASE3Enrolling by invitationINTERVENTIONAL
Enrollment

290

Participants

Timeline

Start Date

July 31, 2016

Primary Completion Date

September 30, 2028

Study Completion Date

February 28, 2029

Conditions
Pulmonary Emphysema in Alpha-1 Antitrypsin Deficiency
Interventions
BIOLOGICAL

Alpha-1 MP

Alpha-1 MP 60 mg/kg/week for up to 104 weeks

Trial Locations (27)

2010

St Vincent's Hospital Sydney, Darlinghurst

2025

NZ Respiratory and Sleep Institute, Auckland

2900

Gentofte Hospital, Hellerup

3065

St Vincent's Hospital Melbourne, Fitzroy

3200

Waikato Hospital, Hamilton

4032

The Prince Charles Hospital, Chermside

5000

Royal Adelaide Hospital, Adelaide

6009

Institute for Respiratory Health Inc, Nedlands

8000

Arhus Universitetshospital, Arhus C

8011

Christchurch Hospital NZ, Christchurch

11361

Karolinska Trial Allicance, KTA Prim, Stockholm

13419

North Estonia Medical Centre Foundation, Tallinn

20502

Skånes Universitetssjukhus, Malmö, Malmo

20520

Turun yliopistollinen keskussairaala, Turku

28401

Accellacare, Wilmington

29425

Medical University of South Carolina, Charleston

33136

University Of Miami Hospital, Doctors Office West Building, Miami

69677

CHU Lyon - 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

656038

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

B3H 3A7

Queen Elizabeth II Health Sciences Centre, Halifax

M5T 3A9

Inspiration Research Limited, Toronto

31-066

SPZOZ Szpital Uniwersytecki w Krakowie, Krakow

01-138

Instytut Gruzlicy i Chorob Pluc w Warszawie, Warsaw

413 45

Sahlgrenska Sjukhuset, Gothenburg

Sponsors
All Listed Sponsors
lead

Grifols Therapeutics LLC

INDUSTRY