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

Hereditary Angioedema Clinical Trial

— CHANGE 3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462709
• Other study ID #: LEVP2006-4
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2006
• Est. completion date: March 31, 2009

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: March 31, 2009
• Est. primary completion date: March 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

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

Locations

Country	Name	City	State
United States	Family Allergy and Asthma Center	Atlanta	Georgia
United States	MeritCare Clinical Research	Bemidji	Minnesota
United States	Allergy and Asthma Clinic of Northwest Arkansas	Bentonville	Arkansas
United States	Legacy Pharma Research	Bismarck	North Dakota
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Graves-Gilbert Clinic	Bowling Green	Kentucky
United States	Montefiore Medical Center	Bronx	New York
United States	University Consultants in Allergy & Immunology	Chicago	Illinois
United States	Nationwide Childrens Hospital Clinical Research	Columbus	Ohio
United States	AARA Research Center	Dallas	Texas
United States	Oregon Medical Group	Eugene	Oregon
United States	Welborn Clinic	Evansville	Indiana
United States	MeritCare Clinical Research	Fargo	North Dakota
United States	Allergy and Asthma Center	Fort Lauderdale	Florida
United States	University of Texas Medical Branch	Galveston	Texas
United States	Allergy Partners of East Carolina	Greenville	North Carolina
United States	Private Practice	Hastings-on-Hudson	New York
United States	Penn State University	Hershey	Pennsylvania
United States	Clinical Research Consultants, Inc	Hoover	Alabama
United States	University of Texas - Pediatric Pulmonary/Allergy and Immunology	Houston	Texas
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Allergy Asthma and Dermatology Research Center	Lake Oswego	Oregon
United States	Nevada Access to Research and Education Society	Las Vegas	Nevada
United States	Private Practice	Liberal	Kansas
United States	UCLA-David Geffen School of Medicine	Los Angeles	California
United States	Family Asthma and Allergy Research Center	Louisville	Kentucky
United States	Winthrop University Hospital	Mineola	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	UMDNJ Asthma and Allergy Research Center	Newark	New Jersey
United States	Olathe Medical Center	Olathe	Kansas
United States	Allergy and Asthma Center of East Orlando	Orlando	Florida
United States	St. Joseph's Hospital/Cornerstone Healthcare	Parkersburg	West Virginia
United States	Virginia Adult and Pediatric Allergy and Asthma	Richmond	Virginia
United States	St. Louis University School of Medicine	Saint Louis	Missouri
United States	Allergy and Asthma Research Center	San Antonio	Texas
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 Immunology Associates	Scottsdale	Arizona
United States	Marycliff Allergy Specialists	Spokane	Washington
United States	Atlanta Allergy and Asthma Clinic	Suwanee	Georgia
United States	Puget Sound Allergy, Asthma and Immunology	Tacoma	Washington
United States	Grand Traverse Allergy	Traverse City	Michigan
United States	Allergy Clinic of Tulsa	Tulsa	Oklahoma
United States	Asthma Allergy and Sinus Center	Waldorf	Maryland
United States	Allergy and Asthma Clinical Research, Inc	Walnut Creek	California
United States	Cleveland Clinic	Weston	Florida
United States	Institute for Asthma and Allergy	Wheaton	Maryland
United States	Tyler County Hospital	Woodville	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antigenic C1 Inhibitor (C1INH) Serum Levels	Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.	Pre-infusion to 1 hour post-infusion
Other	Functional C1INH Serum Levels	Change from pre-infusion to 1 hour post-infusion in functional C1INH serum levels. Functional C1INH serum levels are expressed as a percent of total detectable C1INH (i.e., functional C1INH/total detectable C1INH).	Pre-infusion to 1 hour post-infusion
Other	Complement C4 Serum Levels	Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.	Pre-infusion to 1 hour post-infusion
Primary	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