C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks

Completed · Phase 3 · Has a placebo group

Conditions studied: Hereditary Angioedema

In brief

The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

Key facts

Study ID

NCT00289211

Run by

Shire

People needed

83

Starts

2005-03-14

Expected to finish

2007-04-13

Last updated by the study team

2021-06-11

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Documented HAE
• Normal C1q level

You may not qualify if…

• Low C1q level
• B-cell malignancy
• Presence of anti-C1INH autoantibody
• History of allergic reaction to C1INH or other blood products
• Narcotic addiction
• Current participation in any other investigational drug study or within the past 30 days
• Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
• Pregnancy or lactation
• Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in the study

Where it is running

• Clinical Research Consultants, Inc — Hoover, Alabama, United States
• Allergy and Immunology Associates — Scottsdale, Arizona, 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
• University of Iowa Hospital and Clinic — Iowa City, Iowa, United States
• The Baton Rouge Clinic, AMC — Baton Rouge, Louisiana, United States
• Institute for Asthma and Allergy — Wheaton, Maryland, United States
• Allergy Asthma and Immunology — Falmouth, Massachusetts, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Grand Traverse Allergy — Traverse City, Michigan, United States
• St. Louis University School of Medicine — St Louis, Missouri, 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
• Duke University Medical Center — Durham, North Carolina, United States
• MeritCare Clinical Research — Fargo, North Dakota, United States
• Bernstein Clinical Research — Cincinnati, Ohio, United States
• Optimed Research — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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