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Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01467947
First received: November 7, 2011
Last updated: October 16, 2015
Last verified: October 2015
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hereditary Angioedema Types I and II
Intervention: Biological: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
60 subjects were screened and enrolled in the study. 14 subjects did not experience an HAE attack before the study ended and so did not receive study treatment. 46 subjects started and completed the active treatment period of the study.

Reporting Groups
  Description
C1 Esterase Inhibitor Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.

Participant Flow:   Overall Study
    C1 Esterase Inhibitor
STARTED   46 
COMPLETED   46 
NOT COMPLETED   0 



  Baseline Characteristics
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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
C1 Esterase Inhibitor Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.

Baseline Measures
   C1 Esterase Inhibitor 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Participants]
 
<=18 years   2 
Between 18 and 65 years   42 
>=65 years   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.9  (14.42) 
Gender 
[Units: Participants]
 
Female   32 
Male   14 
Region of Enrollment 
[Units: Participants]
 
Romania   15 
Hungary   8 
Poland   13 
Bulgaria   10 


  Outcome Measures
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1.  Primary:   Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies   [ Time Frame: Baseline to approximately 9 months ]

2.  Secondary:   Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies   [ Time Frame: Baseline to approximately 9 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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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: Program Director, Clinical R&D
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com



Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT01467947     History of Changes
Other Study ID Numbers: CE1145_4001
2010-024242-30 ( EudraCT Number )
Study First Received: November 7, 2011
Results First Received: October 16, 2015
Last Updated: October 16, 2015
Health Authority: United States: Food and Drug Administration
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products