Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment 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 repeat use of C1INH-nf for the treatment of acute HAE attacks.

Key facts

Study ID

NCT00438815

Run by

Shire

People needed

113

Starts

2006-09-21

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…

• This study was open to all subjects who:
• Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up
• Completed participation in LEVP2005-1/B any time after the final prophylactic therapy in Part B
• Were enrolled but not randomized in LEVP2005-1/A after Part A was closed
• Were excluded from LEVP2005-1 for any of the following reasons:
• Pregnancy or lactation
• Age less than 6 years
• Narcotic addiction
• Presence of anti-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
• Received blood or a blood product in the past 60 days other than C1INH-nf

Where it is running

• 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 Clinical Research, Inc — Walnut Creek, California, United States
• Allergy and Asthma Center — Fort Lauderdale, Florida, United States
• Orlando Regional Healthcare — Orlando, Florida, United States
• Family Allergy and Asthma Center — Atlanta, Georgia, United States
• Welborn Clinic Allergy and Immunology — Evansville, Indiana, United States
• Institute for Asthma and Allergy — Wheaton, Maryland, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Grand Traverse Allergy — Traverse City, Michigan, United States
• MeritCare Clinical Research — Bemidji, Minnesota, United States
• Nevada Access to Research and Education Society — Las Vegas, Nevada, United States
• UMDNJ Asthma and Allergy Research Center — Newark, New Jersey, United States
• Winthrop University Hospital — Mineola, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• MeritCare Clinical Research — Fargo, North Dakota, United States
• Allergy & Asthma Centre of Dayton — Centerville, Ohio, United States
• Allergy Clinic of Tulsa — Tulsa, Oklahoma, United States
• Allergy Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• Penn State University — Hershey, Pennsylvania, United States
• Allergy Partners of the Upstate — Greenville, South Carolina, United States
• AARA Research Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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