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Trial record 2 of 237 for:    "Emphysema"
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Extension Study of Zemaira i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00670007
First received: April 29, 2008
Last updated: May 15, 2013
Last verified: May 2013
History of Changes
  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 4

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:

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: 135
Study Start Date: April 2008
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 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

  Show 23 Study Locations
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, 2007-007129-38
Study First Received: April 29, 2008
Last Updated: May 15, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee
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
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Romania: National Medicines Agency
Sweden: Medical Products Agency

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:
Emphysema
Pulmonary Emphysema
Subcutaneous Emphysema
Alpha 1-Antitrypsin Deficiency
Liver Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 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 May 21, 2013