Last updated on December 2016

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


Brief description of study

This is a multi-center, randomized, placebo-controlled, double blind clinical study to assess the efficacy and safety of two separate dose regimens of Alpha-1 MP versus placebo for 156 weeks (i.e., 3 years) using computed tomography (CT) of the lungs as the main measure of efficacy. The two Alpha-1 MP doses to be tested are 60 mg/kg and 120 mg/kg administered weekly by IV infusion for 156 weeks. The study consists of a Screening Phase, a 156-week Treatment Phase, and an End of Study Visit at Week 160.

Clinical Study Identifier: NCT01983241

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Rajat Walia, MD

St. Joseph's Hospital and Medical Center
Phoenix, AZ United States
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Mark Brantly, MD

University of Florida
Gainesville, FL United States
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Michael Campos, MD

University of Miami Miller School of Medicine
Miami, FL United States
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Mitchell D Lee, MD

PMG Research
Wilmington, NC United States
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Alan Barker, MD

Oregon Health & Science University
Portland, OR United States
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Timothy Craig, DO

Penn State Univ. Milton S. Hershey Medical Center
Hershey, PA United States
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Rahul Argula, MBBS, MPH

Medical University of South Carolina
Charleston, SC United States
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James Stocks, MD

University of Texas Health Center at Tyler
Tyler, TX United States
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Mariano Fernandez Acquier

Hospital del Torax Dr. Antonio A. Cetrangolo
Vicente Lopez, Argentina
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Marcos Langer

Centro Dr. Lazaro Langer
Cordoba, Argentina
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Allan Glanville, MD

St Vincent's Hospital Sydney
Sydney, Australia
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Andreas Fiene, MD

The Prince Charles Hospital
Chermside, Australia
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Mark Holmes, MD

Royal Adelaide Hospital
Adelaide, Australia
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Chong Ong, MD

St Vincent's Hospital Melbourne
Fitzroy, Australia
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Martin Phillips, MD

to Institute for Respiratory Health Inc
Nedlands, Australia
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Elie Fiss

Faculdade de Medicina do ABC
Santo André, Brazil
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José Roberto de Brito Jardim

UNIFESP - Universidade Federal de S o Paulo
São Paulo, Brazil
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Alberto Cukier

Instituto do Cora o - Incor- HCFMUSP
São Paulo, Brazil
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Paul Hernandez, MD

Queen Elizabeth II Health Sciences Centre
Halifax, NS Canada
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Kenneth Chapman, MD

Inspiration Research Limited
Toronto, ON Canada
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Tina Skjold, MD

rhus Universitetshospital
Arhus C, Denmark
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Niels Seersholm, MD

Gentofte Hospital
Gentofte, Denmark
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Pille Mukk, MD

North Estonia Medical Centre Foundation
Tallinn, Estonia
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Rain Jogi, MD

Tartu University Hospital
Tartu, Estonia
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Claire Dromer, MD

Groupe Hospitalier Sud - H pital Haut-L v que
Pessac, France
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Jean-François Mornex, MD

H pital Cardio-Vasculaire et Pneumologique Louis Pradel
Bron, France
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Felix Herth

Universitaetsklinikum Heidelberg
Heidelberg, Germany
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Tim Greulich

Universitaetsklinikum Giessen und Marburg GmbH
Marburg, Germany
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Helmut Teschler

Ruhrlandklinik
Essen, Germany
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Robert Bals

Univer des Saarlandes Innere
Homburg Saar, Germany
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Jeff Garrett, MD

New Zealand Respiratory and Sleep institute
Auckland, New Zealand
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Michael Epton, MD

Christchurch Hospital NZ
Christchurch, New Zealand
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Catherina Chang, MD

Waikato Hospital
Hamilton, New Zealand
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Krzysztof Sladek, MD

SPZOZ Szpital Uniwersytecki w Krakowie
Krakow, Poland
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Joanna Chorostowska-Wynimko, MD

Instytut Gruzlicy i Chorob Pluc w Warszawie
Warszawa, Poland
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Lavinia Davidescu

Clinic Dr.G Curteanu Oradea
Oradea, Romania
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Susan Sorrells

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie
Timisoara, Romania
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Irina Tseimakh

SBEI HPE Altai State Medical University of MoH and SD
Barnaul, Russian Federation
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Andrey Belevskiy

FSI Scientific Research Institute of Pulmonology
Moscow, Russian Federation
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Juan Bautista Galdiz Iturri, MD

Hospital de Cruces
Barakaldo, Spain
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Dan Curiac, MD

Sahlgrenska Sjukhuset
Göteborg, Sweden
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Folke Sjoberg, MD

CTC - Clinical Trial Consultants AB
Malmo, Sweden
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Eeva Piitulainen, MD

Sk nes Universitetssjukhus, Malm
Malmö, Sweden
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Michael Runold, MD

Karolinska Universitetssjukhuset, Solna
Stockholm, Sweden
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