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

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ClinicalTrials.gov Identifier: NCT00462709
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : May 3, 2010
Last Update Posted : April 15, 2014
Sponsor:
Information provided by:
Shire

Tracking Information
First Submitted Date  ICMJE April 17, 2007
First Posted Date  ICMJE April 19, 2007
Results First Submitted Date  ICMJE March 31, 2010
Results First Posted Date  ICMJE May 3, 2010
Last Update Posted Date April 15, 2014
Study Start Date  ICMJE June 2006
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2010)
Frequency of All HAE Attacks [ Time Frame: Duration of the study ]
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
Original Primary Outcome Measures  ICMJE
 (submitted: April 17, 2007)
The presence or absence of unequivocal beginning of relief of the defining symptom within 4 hours.
Change History Complete list of historical versions of study NCT00462709 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2007)
  • Change in time to the unequivocal beginning of relief of the defining symptom for subjects who receive multiple treatments.
  • The ability of C1INH-nf concentrate to raise C1INH and C4 levels.
  • Safety will be assessed by the number and severity of adverse experiences, and changes in clinical laboratory safety parameters.
Current Other Pre-specified Outcome Measures
 (submitted: March 19, 2014)
  • Antigenic C1 Inhibitor (C1INH) Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]
    Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.
  • Functional C1INH Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]
    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).
  • Complement C4 Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]
    Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Official Title  ICMJE LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks
Brief Summary The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hereditary Angioedema
Intervention  ICMJE Biological: C1 esterase inhibitor [human] (C1INH-nf)
Study Arms  ICMJE Experimental: Open-label C1INH-nf
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
Intervention: Biological: C1 esterase inhibitor [human] (C1INH-nf)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2010)
146
Original Enrollment  ICMJE
 (submitted: April 17, 2007)
50
Actual Study Completion Date  ICMJE March 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

- History of at least 1 HAE attack per month or any history of laryngeal edema

In addition, this study was open to all subjects who:

  • Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
  • Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
  • Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
  • Were excluded from LEVP2005-1 for any of the following reasons:

    • Pregnancy or lactation
    • Age less than 6 years
    • Narcotic addiction
    • Presence of anti-C1 inhibitor (C1INH) autoantibodies
  • Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:

    • Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
    • Had a known HAE-causing C1INH mutation, or
    • Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator

Exclusion Criteria:

  • History of allergic reaction to C1INH or other blood products
  • Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals
  • Received blood or a blood product in the past 60 days other than C1INH-nf
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00462709
Other Study ID Numbers  ICMJE LEVP2006-4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Scientific Officer, ViroPharma
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruce Zuraw, MD University of California, San Diego
PRS Account Shire
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP