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

• Status: Completed
• Trial end date: 2007-08-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shire
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

Inclusion Criteria:

• Documented HAE

• Normal C1q level

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

Exclusion Criteria:

• 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