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Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 3)

This study has been completed.
Sponsor:
Information provided by:
ViroPharma
ClinicalTrials.gov Identifier:
NCT00462709
First received: April 17, 2007
Last updated: May 7, 2010
Last verified: May 2010
History of Changes
Results First Received: March 31, 2010  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Hereditary Angioedema
Intervention: Biological: C1 esterase inhibitor [human] (C1INH-nf)

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Open-label C1INH-nf 1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.

Participant Flow:   Overall Study
    Open-label C1INH-nf  
STARTED     146  
COMPLETED     79  
NOT COMPLETED     67  
Transitioned to commercial C1INH-nf                 40  
Lost to Follow-up                 10  
Withdrawal by Subject                 8  
Transferred to LEVP2006-1 (NCT00438815)                 3  
Death                 2  
Logistical reasons                 2  
Physician Decision                 1  
Withdrew to start treatment with Cetor                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Open-label C1INH-nf 1,000 U of C1INH-nf administered IV every 3 to 7 days.

Baseline Measures
    Open-label C1INH-nf  
Number of Participants  
[units: participants]
 		  146  
Age  
[units: years]
Mean ± Standard Deviation 		  36.5  ± 16.48  
Gender  
[units: participants]
 		 
Female     112  
Male     34  



  Outcome Measures
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1.  Primary:   Frequency of All HAE Attacks   [ Time Frame: Duration of the study ]
  Show Outcome Measure 1

2.  Other Pre-specified:   Antigenic C1 Inhibitor (C1INH) Serum Levels   [ Time Frame: Pre-infusion to 1 hour post-infusion ]
  Show Outcome Measure 2

3.  Other Pre-specified:   Functional C1INH Serum Levels   [ Time Frame: Pre-infusion to 1 hour post-infusion ]
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Measure Type Other Pre-specified
Measure Title Functional C1INH Serum Levels
Measure Description

Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels.

Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH).
Time Frame Pre-infusion to 1 hour post-infusion  
Safety Issue No  

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.
ITT-E subjects with data at both sampling time points (N=132).

Reporting Groups
  Description
Open-label C1INH-nf 1,000 U of C1INH-nf administered IV every 3 to 7 days.

Measured Values
    Open-label C1INH-nf  
Number of Participants Analyzed  
[units: participants]
 		  132  
Functional C1INH Serum Levels  
[units: percent]
Mean ± Standard Deviation 		 
Pre-infusion     42.0  ± 25.85  
Percent increase at 1 hour post-infusion     30.4  ± 18.05  

No statistical analysis provided for Functional C1INH Serum Levels



4.  Other Pre-specified:   Complement C4 Serum Levels   [ Time Frame: Pre-infusion to 1 hour post-infusion ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


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.  


Results Point of Contact:  
Name/Title: Chief Scientific Officer
Organization: ViroPharma
phone: 610-458-7300


No publications provided by ViroPharma

Publications automatically indexed to this study:


Responsible Party: Chief Scientific Officer, ViroPharma
ClinicalTrials.gov Identifier: NCT00462709     History of Changes
Other Study ID Numbers: LEVP2006-4
Study First Received: April 17, 2007
Results First Received: March 31, 2010
Last Updated: May 7, 2010
Health Authority: United States: Food and Drug Administration