C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00292981
First received: February 15, 2006
Last updated: March 30, 2014
Last verified: October 2011
  Purpose

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 Intervention Phase
Hereditary Angioedema
Drug: C1 Esterase Inhibitor
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by CSL Behring:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    The start of symptom relief was determined by subject self-assessment.

  • Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) [ Time Frame: Up to 24 h after start of study treatment ] [ Designated as safety issue: No ]
    The start of symptom relief was determined by subject self-assessment.


Secondary Outcome Measures:
  • Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) [ Time Frame: Up to Day 9 following an attack ] [ Designated as safety issue: No ]
    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.

  • Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) [ Time Frame: Up to Day 9 following an attack ] [ Designated as safety issue: No ]
    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.


Enrollment: 57
Study Start Date: August 2005
Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00292981

Locations
United States, Florida
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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
Study Director: Program Director CSL Behring
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00292981     History of Changes
Other Study ID Numbers: CE1145_3003, 1453
Study First Received: February 15, 2006
Results First Received: May 25, 2011
Last Updated: March 30, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by CSL Behring:
C1 Inhibitor
Hereditary angioedema
Acute HAE attack

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein
Complement C1
Complement C1s
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014