C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
LEVP2005-1/Part A: A Double-blind, Placebo-Controlled, Clinical Study to Investigate the Efficacy and Safety of Purified C1 Esterase Inhibitor (Human) for the Treatment of HAE in Acute Attacks
1 other identifier
interventional
83
1 country
37
Brief Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2005
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2005
CompletedFirst Submitted
Initial submission to the registry
February 7, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2007
CompletedResults Posted
Study results publicly available
June 2, 2010
CompletedJune 11, 2021
June 1, 2021
2.1 years
February 7, 2006
March 17, 2010
June 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Beginning of Substantial Relief of the Defining Symptom
Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments.
Within 4 hours after initial treatment
Secondary Outcomes (5)
Number of Subjects With Beginning of Substantial Relief of the Defining Symptom
Within 4 hours after initial treatment
Time to Complete Resolution of the HAE Attack
72 hours
Antigenic C1 Inhibitor (C1INH) Serum Levels
Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion
Functional C1INH Serum Levels
Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion
Complement C4 Serum Levels
Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion
Study Arms (2)
C1INH-nf
EXPERIMENTAL1,000 Units (U) of C1INH-nf administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
Placebo
PLACEBO COMPARATORMatching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
Interventions
Eligibility Criteria
You may qualify if:
- Documented HAE
- Normal C1q level
You may not qualify if:
- Low C1q level
- B-cell malignancy
- Presence of anti-C1INH autoantibody
- History of allergic reaction to C1INH or other blood products
- Narcotic addiction
- Current participation in any other investigational drug study or within the past 30 days
- Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days
- Pregnancy or lactation
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (37)
Clinical Research Consultants, Inc
Hoover, Alabama, 35216, United States
Allergy and Immunology Associates
Scottsdale, Arizona, 85251, United States
UCLA-David Geffen School of Medicine
Los Angeles, California, 90095, United States
University of California, San Diego
San Diego, California, 92093-0732, United States
Allergy and Asthma Clinical Research, Inc
Walnut Creek, California, 94598, United States
Allergy and Asthma Center
Fort Lauderdale, Florida, 33334, United States
Orlando Regional Healthcare
Orlando, Florida, 32806, United States
Family Allergy and Asthma Center
Atlanta, Georgia, 30342, United States
Welborn Clinic Allergy and Immunology
Evansville, Indiana, 47713, United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, 52242, United States
The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana, 70808, United States
Institute for Asthma and Allergy
Wheaton, Maryland, 20902, United States
Allergy Asthma and Immunology
Falmouth, Massachusetts, 02550, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Grand Traverse Allergy
Traverse City, Michigan, 49684, United States
St. Louis University School of Medicine
St Louis, Missouri, 63110, United States
Nevada Access to Research and Education Society
Las Vegas, Nevada, 89102, United States
UMDNJ Asthma and Allergy Research Center
Newark, New Jersey, 07103, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
MeritCare Clinical Research
Fargo, North Dakota, 58122, United States
Bernstein Clinical Research
Cincinnati, Ohio, 45231, United States
Optimed Research
Columbus, Ohio, 43235, United States
Allergy Clinic of Tulsa
Tulsa, Oklahoma, 74133, United States
Allergy Asthma and Dermatology Research Center
Lake Oswego, Oregon, 97035, United States
Penn State University
Hershey, Pennsylvania, 17033, United States
Allergy Partners of the Upstate
Greenville, South Carolina, 29615, United States
AARA Research Center
Dallas, Texas, 75231, United States
University of Texas Medical Branch
Galveston, Texas, 77555-1083, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Allergy and Asthma Research Center
San Antonio, Texas, 78229, United States
Virginia Adult and Pediatric Allergy and Asthma
Richmond, Virginia, 23229, United States
Marycliff Allergy Specialists
Spokane, Washington, 99204, United States
Puget Sound Allergy, Asthma and Immunology
Tacoma, Washington, 98405, United States
Allergy, Asthma and Pulmonary Clinical Research
Madison, Wisconsin, 53792, United States
Related Publications (3)
Lumry W, Manning ME, Hurewitz DS, Davis-Lorton M, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1-esterase inhibitor for the acute management and prevention of hereditary angioedema attacks due to C1-inhibitor deficiency in children. J Pediatr. 2013 May;162(5):1017-22.e1-2. doi: 10.1016/j.jpeds.2012.11.030. Epub 2013 Jan 11.
PMID: 23312695DERIVEDGrant JA, White MV, Li HH, Fitts D, Kalfus IN, Uknis ME, Lumry WR. Preprocedural administration of nanofiltered C1 esterase inhibitor to prevent hereditary angioedema attacks. Allergy Asthma Proc. 2012 Jul-Aug;33(4):348-53. doi: 10.2500/aap.2012.33.3585.
PMID: 22856635DERIVEDZuraw BL, Busse PJ, White M, Jacobs J, Lumry W, Baker J, Craig T, Grant JA, Hurewitz D, Bielory L, Cartwright WE, Koleilat M, Ryan W, Schaefer O, Manning M, Patel P, Bernstein JA, Friedman RA, Wilkinson R, Tanner D, Kohler G, Gunther G, Levy R, McClellan J, Redhead J, Guss D, Heyman E, Blumenstein BA, Kalfus I, Frank MM. Nanofiltered C1 inhibitor concentrate for treatment of hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):513-22. doi: 10.1056/NEJMoa0805538.
PMID: 20818886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2006
First Posted
February 9, 2006
Study Start
March 14, 2005
Primary Completion
April 13, 2007
Study Completion
April 13, 2007
Last Updated
June 11, 2021
Results First Posted
June 2, 2010
Record last verified: 2021-06