Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

• Status: Completed
• Trial end date: 2007-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The study objective was to describe the pharmacokinetics (PK) of one or two doses of C1 esterase inhibitor (C1INH-nf) in hereditary angioedema (HAE) subjects who were not experiencing an HAE attack.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Enrolled in LEVP2005-1 (current or in the past)

Exclusion Criteria:

• C1 inhibitor infusion within the last 7 days

• Signs of any HAE attack

• HAE attack within 7 days before actual infusion of C1INH-nf

• Change in the dosage of androgens in the last 14 days before the study

• Use of antifibrinolytics in the last 7 days before the study

• Change in oral conceptive medication in the last two months before the study

• History of clinically relevant antibody development to C1 inhibitor

• Use of oral anticoagulant medication in the last 14 days

• Use of heparin within the last two days prior to the study

• History of allergic reaction to C1 inhibitor or other blood products

• Current participation (or within the past 90 days) in any investigational drug study other than those sponsored by Lev Pharmaceuticals

• Pregnancy or lactation

• B-cell malignancy

• 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