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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

April 29, 2008
May 15, 2013
April 2008
September 2014   (final data collection date for primary outcome measure)
Lung density measured by CT [ Time Frame: Yearly ] [ Designated as safety issue: No ]
Lung Density measured by CT scans [ Time Frame: Yearly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00670007 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Pulmonary Exacerbations [ Time Frame: ongoing ] [ Designated as safety issue: No ]
  • Pulmonary Function [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • Antigenic and functional serum A1 - PI Levels [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: Quarterly ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Yearly ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Extension Study of Zemaira i.v. Administration in Subjects With Emphysema Due to alpha1-proteinase Inhibitor Deficiency.
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

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).
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • Alpha 1-proteinase Inhibitor Deficiency
Biological: Alpha 1- proteinase inhibitor [human]
Lyophilized preparation of 60 mg/kg body weight intravenously once per week
Other Name: Zemaira®
Experimental: Zemaira
Intervention: Biological: Alpha 1- proteinase inhibitor [human]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
135
September 2014
September 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Czech Republic,   Denmark,   Estonia,   Finland,   Germany,   Ireland,   Poland,   Romania,   Sweden
 
NCT00670007
CE1226_3001, 1466, 2007-007129-38
Not Provided
CSL Behring
CSL Behring
Not Provided
Study Director: Program Director, Clinical R&D CSL Behring
CSL Behring
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP