Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Completed · Phase 3
Conditions studied: Hereditary Angioedema
In brief
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
Key facts
- Study ID
- NCT00462709
- Run by
- Shire
- People needed
- 146
- Starts
- 2006-06-27
- Expected to finish
- 2009-03-31
- Last updated by the study team
- 2021-06-08
Who can join
Age: 1 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Clinical Research Consultants, Inc — Hoover, Alabama, United States
- Allergy and Immunology Associates — Scottsdale, Arizona, United States
- Allergy and Asthma Clinic of Northwest Arkansas — Bentonville, Arkansas, United States
- UCLA-David Geffen School of Medicine — Los Angeles, California, United States
- University of California, San Diego — San Diego, California, United States
- Allergy and Asthma Associates of Santa Clara — San Jose, California, United States
- Allergy and Asthma Clinical Research, Inc — Walnut Creek, California, United States
- Allergy and Asthma Center — Fort Lauderdale, Florida, United States
- Allergy and Asthma Center of East Orlando — Orlando, Florida, United States
- Cleveland Clinic — Weston, Florida, United States
- Family Allergy and Asthma Center — Atlanta, Georgia, United States
- Atlanta Allergy and Asthma Clinic — Suwanee, Georgia, United States
- University Consultants in Allergy & Immunology — Chicago, Illinois, United States
- Welborn Clinic — Evansville, Indiana, United States
- Private Practice — Liberal, Kansas, United States
- Olathe Medical Center — Olathe, Kansas, United States
- Graves-Gilbert Clinic — Bowling Green, Kentucky, United States
- Family Asthma and Allergy Research Center — Louisville, Kentucky, United States
- Asthma Allergy and Sinus Center — Waldorf, Maryland, United States
- Institute for Asthma and Allergy — Wheaton, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Grand Traverse Allergy — Traverse City, Michigan, United States
- MeritCare Clinical Research — Bemidji, Minnesota, United States
- University of Mississippi Medical Center — Jackson, Mississippi, United States
- St. Louis University School of Medicine — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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