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
  Purpose

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


Condition Intervention Phase
Hereditary Angioedema
Biological: C1 esterase inhibitor [human] (C1INH-nf)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Enrollment: 146
Study Start Date: June 2006
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-label C1INH-nf
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
Biological: C1 esterase inhibitor [human] (C1INH-nf)

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00462709

  Hide Study Locations
Locations
United States, Alabama
Clinical Research Consultants, Inc
Hoover, Alabama, United States, 35216
United States, Arizona
Allergy and Immunology Associates
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States, 72712
United States, California
UCLA-David Geffen School of Medicine
Los Angeles, California, United States, 90095
University of California, San Diego
San Diego, California, United States, 92093
Allergy and Asthma Associates of Santa Clara
San Jose, California, United States, 95117
Allergy and Asthma Clinical Research, Inc
Walnut Creek, California, United States, 94598
United States, Florida
Allergy and Asthma Center
Fort Lauderdale, Florida, United States, 33334
Allergy and Asthma Center of East Orlando
Orlando, Florida, United States, 32826
Cleveland Clinic
Weston, Florida, United States, 33331
United States, Georgia
Family Allergy and Asthma Center
Atlanta, Georgia, United States, 30342
Atlanta Allergy and Asthma Clinic
Suwanee, Georgia, United States, 30024
United States, Illinois
University Consultants in Allergy & Immunology
Chicago, Illinois, United States, 60612
United States, Indiana
Welborn Clinic
Evansville, Indiana, United States, 47713
United States, Kansas
Private Practice
Liberal, Kansas, United States, 67901
Olathe Medical Center
Olathe, Kansas, United States, 66061
United States, Kentucky
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
Family Asthma and Allergy Research Center
Louisville, Kentucky, United States, 40215
United States, Maryland
Asthma Allergy and Sinus Center
Waldorf, Maryland, United States, 20602
Institute for Asthma and Allergy
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Grand Traverse Allergy
Traverse City, Michigan, United States, 49684
United States, Minnesota
MeritCare Clinical Research
Bemidji, Minnesota, United States, 56601
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63110
United States, Nevada
Nevada Access to Research and Education Society
Las Vegas, Nevada, United States, 89102
United States, New Jersey
UMDNJ Asthma and Allergy Research Center
Newark, New Jersey, United States, 07103
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10461
Private Practice
Hastings on Hudson, New York, United States, 10706
Winthrop University Hospital
Mineola, New York, United States, 11501
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
Allergy Partners of East Carolina
Greenville, North Carolina, United States, 27858
United States, North Dakota
Legacy Pharma Research
Bismarck, North Dakota, United States, 58501
MeritCare Clinical Research
Fargo, North Dakota, United States, 58122
United States, Ohio
Nationwide Childrens Hospital Clinical Research
Columbus, Ohio, United States, 43205
United States, Oklahoma
Allergy Clinic of Tulsa
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Oregon Medical Group
Eugene, Oregon, United States, 97401
Allergy Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States, 97035
United States, Pennsylvania
Penn State University
Hershey, Pennsylvania, United States, 17033
United States, Texas
AARA Research Center
Dallas, Texas, United States, 75231
University of Texas Medical Branch
Galveston, Texas, United States, 77555-1083
University of Texas - Pediatric Pulmonary/Allergy and Immunology
Houston, Texas, United States, 77030
Allergy and Asthma Research Center
San Antonio, Texas, United States, 78229
Tyler County Hospital
Woodville, Texas, United States, 75979
United States, Virginia
Virginia Adult and Pediatric Allergy and Asthma
Richmond, Virginia, United States, 23229
United States, Washington
Marycliff Allergy Specialists
Spokane, Washington, United States, 99204
Puget Sound Allergy, Asthma and Immunology
Tacoma, Washington, United States, 98405
United States, West Virginia
St. Joseph's Hospital/Cornerstone Healthcare
Parkersburg, West Virginia, United States, 26102
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Bruce Zuraw, MD University of California, San Diego
  More Information

No publications provided by Shire

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Hereditary angioedema
C1 esterase inhibitor (human)

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein
Complement C1
Complement C1s
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014