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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00462709
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : May 3, 2010
Last Update Posted : June 8, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Biological: C1 esterase inhibitor [human] (C1INH-nf) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 27, 2006
Actual Primary Completion Date : March 31, 2009
Actual Study Completion Date : March 31, 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Open-label C1INH-nf
1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 7 days.
 Biological: C1 esterase inhibitor [human] (C1INH-nf)


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of All HAE Attacks [ Time Frame: 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.


Other Outcome Measures:
  1. Antigenic C1 Inhibitor (C1INH) Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]
    Change from pre-infusion to 1 hour post-infusion in antigenic C1INH serum levels.

  2. Functional C1INH Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]
    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).

  3. Complement C4 Serum Levels [ Time Frame: Pre-infusion to 1 hour post-infusion ]
    Change from pre-infusion to 1 hour post-infusion in complement C4 serum levels.


Eligibility Criteria
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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00462709


Locations
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Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00462709    
Other Study ID Numbers: LEVP2006-4
First Posted: April 19, 2007    Key Record Dates
Results First Posted: May 3, 2010
Last Update Posted: June 8, 2021
Last Verified: May 2021
Keywords provided by Takeda ( Shire ):
Hereditary angioedema
C1 esterase inhibitor (human)
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
 Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes
Complement C1s
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents