Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
CHANGE 2
LEVP2006-1 CHANGE 2 Trial (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation Evaluating Efficacy): Open-Label Safety/Efficacy Repeat Exposure Study of C1INH-nf (Human) in the Treatment of Acute HAE Attacks
1 other identifier
interventional
113
1 country
30
Brief Summary
The study objective was to evaluate the safety and efficacy of repeat use 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 P25-P50 for phase_3
Started Sep 2006
Typical duration for phase_3
30 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
September 21, 2006
CompletedFirst Submitted
Initial submission to the registry
February 21, 2007
CompletedFirst Posted
Study publicly available on registry
February 22, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2009
CompletedResults Posted
Study results publicly available
June 9, 2010
CompletedJune 8, 2021
May 1, 2021
2.5 years
February 21, 2007
March 31, 2010
May 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf
Duration of the study (2.5 years)
Percent of HAE Attacks With Substantial Relief of the Defining Symptom
Subjects were to assess their symptoms every 15 minutes up to 4 hours after the initial dose or until substantial relief of the defining symptom was achieved. The conservative analysis defined substantial relief as 3 consecutive assessments of improvement of the defining symptom; any attack that did not have 3 consecutive documented reports of improvement was considered a treatment failure. In the less conservative analysis, attacks also were considered to have responded if clinical improvement of the defining symptom occurred but data were incomplete due to cessation of symptom assessments.
Within 4 hours after initial treatment
Secondary Outcomes (5)
Time to Beginning of Substantial Relief of the Defining Symptom
Within 4 hours after initial treatment
Time to Beginning of Substantial Relief of the Defining Symptom for Subjects Who Received Multiple Treatments
Within 4 hours after initial treatment
Antigenic C1 Inhibitor (C1INH) Serum Levels
Pre-infusion to 1 hour post-infusion
Functional C1INH Serum Levels
Pre-infusion to 1 hour post-infusion
Complement C4 Serum Levels
Pre-infusion to 1 hour post-infusion
Study Arms (1)
Open-label C1INH-nf
EXPERIMENTAL1,000 Units (U) of C1INH-nf administered intravenously. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
Interventions
Eligibility Criteria
You may qualify if:
- This study was open to all subjects who:
- Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up
- Completed participation in LEVP2005-1/B any time after the final prophylactic therapy in Part B
- Were enrolled but not randomized in LEVP2005-1/A after Part A was closed
- Were excluded from LEVP2005-1 for any of the following reasons:
- Pregnancy or lactation
- Age less than 6 years
- Narcotic addiction
- Presence of anti-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
You may not qualify if:
- History of allergic reaction to C1INH or other blood products
- Participated in any other investigational drug study within the past 30 days
- Received blood or a blood product in the past 60 days other than C1INH-nf
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (30)
Allergy and Immunology Associates
Scottsdale, Arizona, 85251, United States
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, 72712, 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
Institute for Asthma and Allergy
Wheaton, Maryland, 20902, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Grand Traverse Allergy
Traverse City, Michigan, 49684, United States
MeritCare Clinical Research
Bemidji, Minnesota, 56601, 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
MeritCare Clinical Research
Fargo, North Dakota, 58122, United States
Allergy & Asthma Centre of Dayton
Centerville, Ohio, 45458, 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
Marycliff Allergy Specialists
Spokane, Washington, 99204, United States
Cornerstone Healthcare
Parkersburg, West Virginia, 26101, United States
Related Publications (5)
Baker JW, Craig TJ, Riedl MA, Banerji A, Fitts D, Kalfus IN, Uknis ME. Nanofiltered C1 esterase inhibitor (human) for hereditary angioedema attacks in pregnant women. Allergy Asthma Proc. 2013 Mar-Apr;34(2):162-9. doi: 10.2500/aap.2013.34.3645.
PMID: 23484892DERIVEDLumry 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: 22856635DERIVEDRiedl MA, Hurewitz DS, Levy R, Busse PJ, Fitts D, Kalfus I. Nanofiltered C1 esterase inhibitor (human) for the treatment of acute attacks of hereditary angioedema: an open-label trial. Ann Allergy Asthma Immunol. 2012 Jan;108(1):49-53. doi: 10.1016/j.anai.2011.10.017. Epub 2011 Nov 21.
PMID: 22192966DERIVEDZuraw 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
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2007
First Posted
February 22, 2007
Study Start
September 21, 2006
Primary Completion
March 31, 2009
Study Completion
March 31, 2009
Last Updated
June 8, 2021
Results First Posted
June 9, 2010
Record last verified: 2021-05