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Trial record 1 of 1 for:    nct00292981
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C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

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ClinicalTrials.gov Identifier: NCT00292981
Recruitment Status : Completed
First Posted : February 16, 2006
Results First Posted : June 23, 2011
Last Update Posted : May 7, 2015
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Description
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Brief Summary:
Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Drug: C1 Esterase Inhibitor Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks
Study Start Date : August 2005
Actual Primary Completion Date : February 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: C1 Esterase Inhibitor Drug: C1 Esterase Inhibitor
Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
Other Name: Berinert P


Outcome Measures
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Primary Outcome Measures :
  1. Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) [ Time Frame: Up to 24 h after start of study treatment ]
    The start of symptom relief was determined by subject self-assessment.

  2. Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) [ Time Frame: Up to 24 h after start of study treatment ]
    The start of symptom relief was determined by subject self-assessment.


Secondary Outcome Measures :
  1. Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) [ Time Frame: Up to Day 9 following an attack ]
    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.

  2. Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) [ Time Frame: Up to Day 9 following an attack ]
    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.


Eligibility Criteria
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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Documented congenital C1-INH deficiency
  • Acute HAE attack
  • Participation in base study CE1145_3001 (NCT00168103)

Key Exclusion Criteria:

  • Acquired angioedema
  • Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry
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): NCT00292981


Locations
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United States, Florida
Contact CSL Behring for facility details
Weston, Florida, United States, 33331
United States, Georgia
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Atlanta, Georgia, United States, 30342
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Chicago, Illinois, United States, 60612-3244
United States, Louisiana
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Shreveport, Louisiana, United States, 71130
United States, Massachusetts
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Boston, Massachusetts, United States, 02115
United States, Minnesota
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Plymouth, Minnesota, United States, 55446
United States, Nebraska
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Omaha, Nebraska, United States, 69131
United States, Oklahoma
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Tulsa, Oklahoma, United States, 74133
United States, Oregon
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Eugene, Oregon, United States, 97401
United States, Pennsylvania
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Hershey, Pennsylvania, United States, 17033
United States, South Dakota
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Rapid City, South Dakota, United States, 57702
United States, Texas
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Dallas, Texas, United States, 75230
Canada, Ontario
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Ottawa, Ontario, Canada, KIY 4G2
Sponsors and Collaborators
CSL Behring
Investigators
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Study Director: Program Director CSL Behring
More Information
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Additional Information:

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00292981    
Other Study ID Numbers: CE1145_3003
1453 ( Other Identifier: CSL Behring )
First Posted: February 16, 2006    Key Record Dates
Results First Posted: June 23, 2011
Last Update Posted: May 7, 2015
Last Verified: October 2011
Keywords provided by CSL Behring:
C1 Inhibitor
Hereditary angioedema
Acute HAE attack
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