C1 Esterase Inhibitor (C1INH-nf) for the Prevention 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 prevention of acute HAE attacks.

Key facts

Study ID

NCT01005888

Run by

Shire

People needed

26

Starts

2005-03-14

Expected to finish

2007-08-22

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
• Relatively frequent angioedema attacks (at least 2 per month on average)

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

• Allergy and Immunology Associates — Scottsdale, Arizona, United States
• University of California, San Diego — San Diego, California, United States
• Allergy and Asthma Clinical Research, Inc — Walnut Creek, California, United States
• Atlanta Allergy and Asthma Clinic — Suwanee, Georgia, United States
• Hawaii Pacific Health Research Institute — Honolulu, Hawaii, United States
• Welborn Clinic Allergy and Immunology — Evansville, Indiana, United States
• Lake Charles Memorial Hospital — Lake Charles, Louisiana, United States
• Institute for Asthma and Allergy — Wheaton, Maryland, United States
• Libby Clinic — Libby, Montana, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Nationwide Childrens Hospital Clinical Research — Columbus, Ohio, United States
• Allergy Clinic of Tulsa — Tulsa, Oklahoma, United States
• Allergy Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• AARA Research Center — Dallas, Texas, United States
• Tyler County Hospital — Woodville, Texas, United States
• St. Joseph's Hospital/Cornerstone Healthcare — Parkersburg, West Virginia, United States

Full record on ClinicalTrials.gov

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