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Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 2)

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00438815
First received: February 21, 2007
Last updated: March 19, 2014
Last verified: March 2014
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: Treatment
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
No text entered.

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). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.

Participant Flow:   Overall Study
    Open-label C1INH-nf  
STARTED     113  
COMPLETED     43  
NOT COMPLETED     70  
Transferred to LEVP2006-4 (NCT00462709)                 30  
3-month follow-up no longer required                 12  
Noncompliance with protocol requirements                 9  
Transitioned to commercial C1INH-nf                 6  
Lost to Follow-up                 6  
Withdrawal by Subject                 6  
Death                 1  



  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
Open-label C1INH-nf 1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.

Baseline Measures
    Open-label C1INH-nf  
Number of Participants  
[units: participants]
  113  
Age  
[units: years]
Mean ± Standard Deviation
  34.5  ± 17.6  
Gender  
[units: participants]
 
Female     75  
Male     38  



  Outcome Measures
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1.  Primary:   Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf   [ Time Frame: Duration of the study (2.5 years) ]

2.  Primary:   Percent of HAE Attacks With Substantial Relief of the Defining Symptom   [ Time Frame: Within 4 hours after initial treatment ]

3.  Secondary:   Time to Beginning of Substantial Relief of the Defining Symptom   [ Time Frame: Within 4 hours after initial treatment ]

4.  Secondary:   Time to Beginning of Substantial Relief of the Defining Symptom for Subjects Who Received Multiple Treatments   [ Time Frame: Within 4 hours after initial treatment ]

5.  Secondary:   Antigenic C1 Inhibitor (C1INH) Serum Levels   [ Time Frame: Pre-infusion to 1 hour post-infusion ]

6.  Secondary:   Functional C1INH Serum Levels   [ Time Frame: Pre-infusion to 1 hour post-infusion ]

7.  Secondary:   Complement C4 Serum Levels   [ Time Frame: Pre-infusion to 1 hour post-infusion ]


  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: Chief Scientific Officer
Organization: ViroPharma
phone: 610-458-7300


No publications provided by Shire

Publications automatically indexed to this study:


Responsible Party: Chief Scientific Officer, ViroPharma
ClinicalTrials.gov Identifier: NCT00438815     History of Changes
Other Study ID Numbers: LEVP2006-1
Study First Received: February 21, 2007
Results First Received: March 31, 2010
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration