Extension Study of Zemaira i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency. - Full Text View

Sponsor:	CSL Behring
Information provided by (Responsible Party):	CSL Behring
ClinicalTrials.gov Identifier:	NCT00670007

Purpose

This study is a continuation of the placebo-controlled study (NCT00261833) to evaluate the efficacy and safety of Zemaira i.v. administration in subjects with emphysema due to alpha1-proteinase inhibitor deficiency. The long-term effect of Zemaira® on the progression of emphysema will be assessed by the decline of lung density, measured by computed tomography (CT).

Condition	Intervention	Phase
Emphysema Alpha 1-proteinase Inhibitor Deficiency	Biological: Alpha 1- proteinase inhibitor [human]	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Open, Non-controlled, Multicenter, Multinational Study to Evaluate the Efficacy and Safety of Zemaira® Administration in Chronic Augmentation and Maintenance Therapy in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency Who Completed Clinical Study CE1226_4001

Resource links provided by NLM:

Genetics Home Reference related topics: alpha-1 antitrypsin deficiency

MedlinePlus related topics: Alpha-1 Antitrypsin Deficiency Emphysema

U.S. FDA Resources

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Lung density measured by CT [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number, severity, and duration of pulmonary exacerbations [ Time Frame: Entire duration of the study ] [ Designated as safety issue: No ]
Lung function as measured by forced expiratory volume in 1 second (FEV1) and ratio FEV1/FVC (forced vital capacity) [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]
Antigenic and functional serum A1 - PI Levels [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]
Body mass index [ Time Frame: Once every 3 months ] [ Designated as safety issue: No ]
Quality of Life [ Time Frame: Yearly ] [ Designated as safety issue: No ]
Mortality [ Time Frame: Duration of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	March 2008
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Zemaira	Biological: Alpha 1- proteinase inhibitor [human] Lyophilized preparation of 60 mg/kg body weight intravenously once per week Other Name: Zemaira®

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects who have completed the 2-year treatment and observation period in the Phase III/IV Zemaira® CE1226_4001 study (NCT00261833) and are willing to sign informed consent
Males, and non-pregnant, non-lactating females, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator

Exclusion Criteria:

Individuals residing in the US
Current evidence of alcohol abuse or abuse of drugs such as barbiturates, benzodiazepines, amphetamines, cocaine, opioids, and cannabinoids
History of allergy, anaphylactic reaction, or severe systemic response to human plasma derived products, or known mannitol hypersensitivity, or history of prior adverse reaction to mannitol
Current tobacco smoker (smoking has to be ceased at least 6 months prior study inclusion)
Conditions or behaviors that interfere with attending scheduled study visits in opinion of the investigator
History of non-compliance
Administration of any other experimental new drug or participation in an investigation of a marketed product
Inability to perform necessary study procedures

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00670007

Locations

Australia, Victoria
Study Site
Fitzroy, Victoria, Australia, 3065
Canada, British Columbia
Study Site
Vancouver, British Columbia, Canada, V5Z4E1
Canada, Nova Scotia
Study Site
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
Study Site
Toronto, Ontario, Canada, M5T 2S8
Estonia
Study Site
Tartu, Estonia, 51014
Finland
Study Site
Oulu, Finland, 90220
Germany
Study Site
Berlin, Germany, 12200
Study Site
Essen, Germany, 45209
Study Site
Heidelberg, Germany, 69126
Ireland
Study Site
Dublin, Ireland, 9
Poland
Study Site
Warsaw, Poland, 01-138
Sweden
Study Site
Malmo, Sweden, 20502

Sponsors and Collaborators

CSL Behring

Investigators

Study Director:

Program Director, Clinical R&D

CSL Behring

More Information

Additional Information:

Click here to request more information about this study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00670007 History of Changes
Other Study ID Numbers:	CE1226_3001, 1466
Study First Received:	April 29, 2008
Last Updated:	February 8, 2012
Health Authority:	United States: Food and Drug Administration; Ireland: Irish Medicines Board; Ireland: Medical Ethics Research Committee; Finland: Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration; Finland: Finnish Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Germany: Paul-Ehrlich-Institut

Keywords provided by CSL Behring:

Alpha1-proteinase inhibitor deficiency
Chronic augmentation and maintenance therapy
Emphysema
Emphysema due to Alpha 1-proteinase inhibitor deficiency

Additional relevant MeSH terms:

Alpha 1-Antitrypsin Deficiency
Emphysema
Pulmonary Emphysema
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Subcutaneous Emphysema

Pathologic Processes
Alpha 1-Antitrypsin
Protease Inhibitors
Trypsin Inhibitors
Serine Proteinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012