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

Study Overview
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Brief Summary
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The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.

Official Title
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LEVP2006-4 CHANGE 3 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Use of C1INH-nf (Human) for the Prophylactic Treatment to Prevent HAE Attacks and as Treatment in Acute HAE Attacks

Conditions
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Hereditary Angioedema

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - History of at least 1 HAE attack per month or any history of laryngeal edema In addition, this study was open to all subjects who: Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up Were excluded from LEVP2005-1 for any of the following reasons: Pregnancy or lactation Age less than 6 years Narcotic addiction Presence of anti-C1 inhibitor (C1INH) autoantibodies Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances: Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or Had a known HAE-causing C1INH mutation, or Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator Exclusion Criteria: History of allergic reaction to C1INH or other blood products Participated in any other investigational drug study within the past 30 days other than those sponsored by Lev Pharmaceuticals Received blood or a blood product in the past 60 days other than C1INH-nf

Ages Eligible for Study
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Minimum Age: 1 Year

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label C1INH-nf<br>1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days. | Biological: 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 |
| --- | --- | --- |
| Frequency of All HAE Attacks | A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema. | Duration of the study | 

 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)