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

Phase 3

Completed

• Conditions: Hereditary Angioedema

• Registration Number: NCT00462709
• Lead Sponsor: Shire

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-27
• Study First Submitted: 2007-04-17
• Study First Submitted QC: 2007-04-17
• Study First Posted: 2007-04-19
• Primary Completion: 2009-03-31
• Study Completion: 2009-03-31
• Results First Submitted: 2010-03-31
• Results First Submitted QC: 2010-04-09
• Results First Posted: 2010-05-03
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-19
• Last Update Posted: 2021-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of All HAE Attacks	Duration of the study	A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.

Trial Locations

Locations (46)

Clinical Research Consultants, Inc; 🇺🇸 Hoover, Alabama, United States

Allergy and Immunology Associates; 🇺🇸 Scottsdale, Arizona, United States

Allergy and Asthma Clinic of Northwest Arkansas; 🇺🇸 Bentonville, Arkansas, United States

UCLA-David Geffen School of Medicine; 🇺🇸 Los Angeles, California, United States

University of California, San Diego; 🇺🇸 San Diego, California, United States

Allergy and Asthma Associates of Santa Clara; 🇺🇸 San Jose, California, United States

Allergy and Asthma Clinical Research, Inc; 🇺🇸 Walnut Creek, California, United States

Allergy and Asthma Center; 🇺🇸 Fort Lauderdale, Florida, United States

Allergy and Asthma Center of East Orlando; 🇺🇸 Orlando, Florida, United States

Cleveland Clinic; 🇺🇸 Weston, Florida, United States

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