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

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ClinicalTrials.gov Identifier: NCT00670007
Recruitment Status : Completed
First Posted : May 1, 2008
Results First Posted : July 12, 2016
Last Update Posted : August 15, 2016
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Emphysema
Alpha 1-proteinase Inhibitor Deficiency
Intervention: Biological: Alpha1- proteinase inhibitor [human]

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

This multicenter study was conducted at 22 centers in Europe, Canada, and Australia.

Alpha1-proteinase inhibitor (A1-PI) deficient individuals with emphysema, who had completed the 2-year treatment and observation periods in study CE1226_4001, except those participating in the USA, were invited to participate in study CE1226_3001.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who had participated in the CE1226_4001 study, met the inclusion and exclusion criteria, and signed the informed consent were included in study CE1226_3001.

Reporting Groups
  Description
Zemaira® Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight administered intravenously once per week

Participant Flow:   Overall Study
    Zemaira®
STARTED   140 
COMPLETED   131 
NOT COMPLETED   9 
Drug abuse                1 
Lung transplant                1 
Travel/Vacation                1 
Adverse event, serious fatal                1 
Adverse Event                1 
Withdrawal by Subject                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Zemaira® Alpha1- proteinase inhibitor [human]: Lyophilized preparation of 60 mg/kg body weight intravenously once per week

Baseline Measures
   Zemaira® 
Overall Participants Analyzed 
[Units: Participants]
 140 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   130 
>=65 years   10 
Gender 
[Units: Participants]
 
Female   61 
Male   79 
Region of Enrollment 
[Units: Participants]
 
Canada   25 
Sweden   17 
Czech Republic   2 
Romania   1 
Ireland   19 
Finland   3 
Poland   4 
Denmark   35 
Australia   17 
Germany   15 
Estonia   2 


  Outcome Measures

1.  Primary:   Rate of Change of Adjusted Lung Density   [ Time Frame: Up to 2 years ]

2.  Secondary:   Absolute Change in Adjusted Lung Density   [ Time Frame: From baseline to 2 years ]

3.  Secondary:   Percent Change in Adjusted Lung Density   [ Time Frame: From baseline to 2 years ]

4.  Secondary:   Change in Subject-reported Symptoms   [ Time Frame: From baseline to 2 years ]

5.  Secondary:   Percent Change in Lung Function as Measured by Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: From baseline up to 2 years ]

6.  Secondary:   Percent Change in Lung Function as Measured by Ratio of FEV1/FVC (Forced Vital Capacity)   [ Time Frame: From baseline up to 2 years ]

7.  Secondary:   Percent Change in Lung Function as Measured by Percent Predicted FEV1   [ Time Frame: From baseline up to 2 years ]

8.  Secondary:   Number of Subjects With Pulmonary Exacerbations   [ Time Frame: Up to 2 years ]

9.  Secondary:   Annual Rate in Subject Years of Pulmonary Exacerbations   [ Time Frame: Up to 2 years ]

10.  Secondary:   Time to First Pulmonary Exacerbation   [ Time Frame: Up to 2 years ]

11.  Secondary:   Percentage of Subjects With Treatment Emergent Adverse Events   [ Time Frame: From baseline up to 2.5 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use Email contact
e-mail: clinicaltrials@cslbehring.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00670007     History of Changes
Other Study ID Numbers: CE1226_3001
1466 ( Other Identifier: CSL Behring )
2007-007129-38 ( EudraCT Number )
First Submitted: April 29, 2008
First Posted: May 1, 2008
Results First Submitted: June 2, 2016
Results First Posted: July 12, 2016
Last Update Posted: August 15, 2016