Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Protocol LEVP2006-5: Pharmacokinetics of C1INH-nf in Hereditary Angioedema Subjects

Conditions
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Hereditary Angioedema

Intervention / Treatment
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* Drug: C1 esterase inhibitor [human] (C1INH-nf)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose<br>1,000 Units (U) of C1INH-nf administered intravenously (IV). | Drug: C1 esterase inhibitor [human] (C1INH-nf)<br> <br> |
| Experimental: First Dose Followed by Second Dose<br>1,000 U of C1INH-nf administered IV, followed by a second 1,000 U dose 60 minutes later. | Drug: C1 esterase inhibitor [human] (C1INH-nf)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time. |  | 1 week | 
| C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation. |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of adverse events. |  | 3 months | 
| Change in clinical laboratory safety parameters from pre- to post-infusion. |  | 3 months | 
| Change in vital signs from pre- to post-infusion. |  | 30 minutes (Single Dose), 90 minutes (First Dose Followed by Second Dose) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hereditary angioedema, C1 esterase inhibitor (human)