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Trial record 48 of 76 for:    ALPHA-1-ANTITRYPSIN DEFICIENCY

Zemaira in Subjects With Emphysema Due to Alpha1-Proteinase Inhibitor Deficiency

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ClinicalTrials.gov Identifier: NCT00261833
Recruitment Status : Completed
First Posted : December 5, 2005
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Alpha1-proteinase Inhibitor Deficiency
Emphysema
Interventions: Biological: Alpha1-proteinase inhibitor
Other: Placebo

  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, multinational study enrolled participants at 28 study centers in Europe, North America, and Australia.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening took place 1 to 4 weeks prior to the first dose of randomized investigational product (ie, either Zemaira® or placebo). A total of 208 participants were screened; 28 of these did not fulfill all eligibility criteria and were therefore screening failures.

Reporting Groups
  Description
Zemaira® Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Placebo Lyophilized preparation: 60 mg/kg body weight/week intravenous

Participant Flow:   Overall Study
    Zemaira®   Placebo
STARTED   93   87 
COMPLETED   84   69 
NOT COMPLETED   9   18 
Death                1                3 
Adverse Event                1                4 
Withdrawal by Subject                5                7 
Protocol Violation                0                1 
Suspicion of pulmonary cancer                0                1 
Lung transplantation                1                1 
Missing reason                1                0 
Not interested in being participant                0                1 



  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.
No text entered.

Reporting Groups
  Description
Zemaira® Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
Placebo Lyophilized preparation: 60 mg/kg body weight/week intravenous
Total Total of all reporting groups

Baseline Measures
   Zemaira®   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 93   87   180 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.81  (6.193)   52.40  (7.812)   53.13  (7.374) 
Gender 
[Units: Participants]
     
Female   45   37   82 
Male   48   50   98 
Baseline percent predicted forced expiratory volume in 1 second (FEV1) 
[Units: Percentage]
Mean (Standard Deviation)
 47.4  (12.1)   47.2  (11.1)   47.3  (11.6) 
Baseline diffusion capacity of carbon monoxide (DLCO) 
[Units: mL/min/mmHg]
Mean (Standard Deviation)
 13.6  (5.3)   15.0  (5.6)   14.3  (5.5) 
Number of participants with ZZ genotype (A1-PI deficiency), or SZ, Z / Null or Other genotype 
[Units: Participants]
     
ZZ   83   83   166 
SZ   2   0   2 
Z / Null   2   1   3 
Other   6   3   9 


  Outcome Measures

1.  Primary:   Annual Rate of Change in Lung Density   [ Time Frame: Over a 2-year period ]

2.  Secondary:   Annual Rate of Pulmonary Exacerbations   [ Time Frame: Over a 2-year period ]

3.  Secondary:   Percent Change in FEV1   [ Time Frame: From baseline to 2 years ]

4.  Secondary:   Time to First Pulmonary Exacerbation   [ Time Frame: Over a 2-year period ]

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

6.  Secondary:   Change in Exercise Capacity   [ Time Frame: From baseline to 2 years ]

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

8.  Secondary:   Frequency and Intensity of Adverse Events (AEs)   [ Time Frame: Over a 2-year period ]

9.  Secondary:   Percent Change in Percent Predicted FEV1   [ Time Frame: From baseline to 2 years ]

10.  Secondary:   Percent Change in FEV1 Divided by Forced Vital Capacity   [ Time Frame: From baseline to 2 years ]

11.  Secondary:   Percent Change in DLCO   [ Time Frame: From baseline to 2 years ]

12.  Secondary:   Duration of Pulmonary Exacerbations Relative to Treatment Duration   [ Time Frame: Over a 2-year period ]

13.  Secondary:   Severity of Pulmonary Exacerbations   [ Time Frame: Over a 2-year period ]

14.  Other Pre-specified:   Baseline Lung Density at Total Lung Capacity (TLC) and Forced Residual Capacity (FRC)   [ Time Frame: Baseline ]


  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
No text entered.


  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: NCT00261833     History of Changes
Other Study ID Numbers: CE1226_4001
1449 ( Other Identifier: CSL Behring )
2005-003459-12 ( EudraCT Number )
First Submitted: December 2, 2005
First Posted: December 5, 2005
Results First Submitted: November 2, 2014
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015