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Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (CHANGE 3)

Primary Purpose

Hereditary Angioedema

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
C1 esterase inhibitor [human] (C1INH-nf)
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hereditary Angioedema focused on measuring Hereditary angioedema, C1 esterase inhibitor (human)

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Consultants, Inc
  • Allergy and Immunology Associates
  • Allergy and Asthma Clinic of Northwest Arkansas
  • UCLA-David Geffen School of Medicine
  • University of California, San Diego
  • Allergy and Asthma Associates of Santa Clara
  • Allergy and Asthma Clinical Research, Inc
  • Allergy and Asthma Center
  • Allergy and Asthma Center of East Orlando
  • Cleveland Clinic
  • Family Allergy and Asthma Center
  • Atlanta Allergy and Asthma Clinic
  • University Consultants in Allergy & Immunology
  • Welborn Clinic
  • Private Practice
  • Olathe Medical Center
  • Graves-Gilbert Clinic
  • Family Asthma and Allergy Research Center
  • Asthma Allergy and Sinus Center
  • Institute for Asthma and Allergy
  • Massachusetts General Hospital
  • Grand Traverse Allergy
  • MeritCare Clinical Research
  • University of Mississippi Medical Center
  • St. Louis University School of Medicine
  • Nevada Access to Research and Education Society
  • UMDNJ Asthma and Allergy Research Center
  • Montefiore Medical Center
  • Private Practice
  • Winthrop University Hospital
  • Mount Sinai School of Medicine
  • Allergy Partners of East Carolina
  • Legacy Pharma Research
  • MeritCare Clinical Research
  • Nationwide Childrens Hospital Clinical Research
  • Allergy Clinic of Tulsa
  • Oregon Medical Group
  • Allergy Asthma and Dermatology Research Center
  • Penn State University
  • AARA Research Center
  • University of Texas Medical Branch
  • University of Texas - Pediatric Pulmonary/Allergy and Immunology
  • Allergy and Asthma Research Center
  • Tyler County Hospital
  • Virginia Adult and Pediatric Allergy and Asthma
  • Marycliff Allergy Specialists
  • Puget Sound Allergy, Asthma and Immunology
  • St. Joseph's Hospital/Cornerstone Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-label C1INH-nf

Arm Description

1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 17, 2007
Last Updated
May 19, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00462709
Brief Title
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 27, 2006 (Actual)
Primary Completion Date
March 31, 2009 (Actual)
Study Completion Date
March 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Angioedema
Keywords
Hereditary angioedema, C1 esterase inhibitor (human)

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-label C1INH-nf
Arm Type
Experimental
Arm Description
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
Intervention Type
Biological
Intervention Name(s)
C1 esterase inhibitor [human] (C1INH-nf)
Primary Outcome Measure Information:
Title
Frequency of All HAE Attacks
Description
A hereditary angioedema (HAE) attack was defined as a discrete episode during which the subject progressed from no angioedema to symptoms of angioedema.
Time Frame
Duration of the study
Other Pre-specified Outcome Measures:
Title
Antigenic C1 Inhibitor (C1INH) Serum Levels
Description
Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.
Time Frame
Pre-infusion to 1 hour post-infusion
Title
Functional C1INH Serum Levels
Description
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).
Time Frame
Pre-infusion to 1 hour post-infusion
Title
Complement C4 Serum Levels
Description
Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.
Time Frame
Pre-infusion to 1 hour post-infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Research Consultants, Inc
City
Hoover
State/Province
Alabama
ZIP/Postal Code
35216
Country
United States
Facility Name
Allergy and Immunology Associates
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Allergy and Asthma Clinic of Northwest Arkansas
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Facility Name
UCLA-David Geffen School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Allergy and Asthma Associates of Santa Clara
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Allergy and Asthma Clinical Research, Inc
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Allergy and Asthma Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Allergy and Asthma Center of East Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32826
Country
United States
Facility Name
Cleveland Clinic
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Family Allergy and Asthma Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Atlanta Allergy and Asthma Clinic
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
University Consultants in Allergy & Immunology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Welborn Clinic
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47713
Country
United States
Facility Name
Private Practice
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Olathe Medical Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Graves-Gilbert Clinic
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Facility Name
Family Asthma and Allergy Research Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Asthma Allergy and Sinus Center
City
Waldorf
State/Province
Maryland
ZIP/Postal Code
20602
Country
United States
Facility Name
Institute for Asthma and Allergy
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Grand Traverse Allergy
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
MeritCare Clinical Research
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Louis University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Nevada Access to Research and Education Society
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
UMDNJ Asthma and Allergy Research Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Private Practice
City
Hastings-on-Hudson
State/Province
New York
ZIP/Postal Code
10706
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Allergy Partners of East Carolina
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27858
Country
United States
Facility Name
Legacy Pharma Research
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
MeritCare Clinical Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Nationwide Childrens Hospital Clinical Research
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Allergy Clinic of Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Facility Name
Oregon Medical Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Allergy Asthma and Dermatology Research Center
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Penn State University
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
AARA Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-1083
Country
United States
Facility Name
University of Texas - Pediatric Pulmonary/Allergy and Immunology
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Allergy and Asthma Research Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler County Hospital
City
Woodville
State/Province
Texas
ZIP/Postal Code
75979
Country
United States
Facility Name
Virginia Adult and Pediatric Allergy and Asthma
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Marycliff Allergy Specialists
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Puget Sound Allergy, Asthma and Immunology
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Joseph's Hospital/Cornerstone Healthcare
City
Parkersburg
State/Province
West Virginia
ZIP/Postal Code
26102
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36326435
Citation
Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.
Results Reference
derived
PubMed Identifier
23484892
Citation
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.
Results Reference
derived
PubMed Identifier
23312695
Citation
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.
Results Reference
derived
PubMed Identifier
20818886
Citation
Zuraw 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.
Results Reference
derived

Learn more about this trial

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

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