Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

Shire

Status and phase: Completed; Phase 1

Conditions: Hereditary Angioedema

Treatments: Drug: C1 esterase inhibitor [human] (C1INH-nf)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00432510

LEVP2006-5

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Single Dose

Experimental group

Description:

1,000 Units (U) of C1INH-nf administered intravenously (IV).

Treatment:

Drug: C1 esterase inhibitor [human] (C1INH-nf)

First Dose Followed by Second Dose

Experimental group

Description:

1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later.

Treatment:

Drug: C1 esterase inhibitor [human] (C1INH-nf)