Overview

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

Status:
Completed
Trial end date:
2007-04-13
Target enrollment:
0
Participant gender:
All
Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment 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

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