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

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ClinicalTrials.gov Identifier: NCT00438815
Recruitment Status : Completed
First Posted : February 22, 2007
Results First Posted : June 9, 2010
Last Update Posted : April 15, 2014
Sponsor:
Information provided by:
Shire

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hereditary Angioedema
Intervention: Biological: C1 esterase inhibitor [human] (C1INH-nf)

  Participant Flow

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

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
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 
Overall Participants Analyzed 
[Units: Participants]
 		 113 
Age 
[Units: Years]
Mean (Standard Deviation) 		 34.5  (17.6) 
Gender 
[Units: Participants]
 		 
Female   75 
Male   38 


  Outcome Measures

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

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

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

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 ]
  Show Outcome Measure 4

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

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

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


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


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


Responsible Party: Chief Scientific Officer, ViroPharma
ClinicalTrials.gov Identifier: NCT00438815     History of Changes
Other Study ID Numbers: LEVP2006-1
First Submitted: February 21, 2007
First Posted: February 22, 2007
Results First Submitted: March 31, 2010
Results First Posted: June 9, 2010
Last Update Posted: April 15, 2014