Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 3)
This study has been completed.
Sponsor:
ViroPharma
Information provided by:
ViroPharma
ClinicalTrials.gov Identifier:
NCT00462709
First received: April 17, 2007
Last updated: May 7, 2010
Last verified: May 2010
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
hereditary angioedema
Drug Information available for:
SERPING1 protein, human
U.S. FDA Resources
Further study details as provided by ViroPharma:
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.
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00462709
Hide Study Locations
Hide Study LocationsLocations
| 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
ViroPharma
Investigators
| Principal Investigator: | Bruce Zuraw, MD | University of California, San Diego |
More Information
No publications provided by ViroPharma
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: | May 7, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by ViroPharma:
|
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 June 18, 2013