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:
Shire
ClinicalTrials.gov Identifier:
NCT00462709
First received: April 17, 2007
Last updated: March 19, 2014
Last verified: March 2014

April 17, 2007
March 19, 2014
June 2006
March 2009   (final data collection date for primary outcome measure)
Frequency of All HAE Attacks [ Time Frame: Duration of the study ] [ Designated as safety issue: No ]
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
The presence or absence of unequivocal beginning of relief of the defining symptom within 4 hours.
Complete list of historical versions of study NCT00462709 on ClinicalTrials.gov Archive Site
Not Provided
  • 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.
  • Antigenic C1 Inhibitor (C1INH) Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.
Not Provided
 
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
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

The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Hereditary Angioedema
Biological: C1 esterase inhibitor [human] (C1INH-nf)
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)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
March 2009
March 2009   (final data collection date for primary outcome measure)

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
Both
1 Year and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00462709
LEVP2006-4
Not Provided
Chief Scientific Officer, ViroPharma
Shire
Not Provided
Principal Investigator: Bruce Zuraw, MD University of California, San Diego
Shire
March 2014

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