C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
This study has been completed.
Sponsor:
CSL Behring
Information provided by:
CSL Behring
ClinicalTrials.gov Identifier:
NCT00292981
First received: February 15, 2006
Last updated: October 6, 2011
Last verified: October 2011
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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:
Genetics Home Reference related topics:
hereditary angioedema
Drug Information available for:
SERPING1 protein, human
U.S. FDA Resources
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00292981
Locations
| United States, Florida | |
| Contact CSL Behring for facility details | |
| Weston, Florida, United States, 33331 | |
| United States, Georgia | |
| Contact CSL Behring for facility details | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Idaho | |
| Contact CSL Behring for facility details | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Contact CSL Behring for facility details | |
| Chicago, Illinois, United States, 60612-3244 | |
| United States, Louisiana | |
| Contact CSL Behring for facility details | |
| Shreveport, Louisiana, United States, 71130 | |
| United States, Massachusetts | |
| Contact CSL Behring for facility details | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Minnesota | |
| Contact CSL Behring for facility details | |
| Plymouth, Minnesota, United States, 55446 | |
| United States, Nebraska | |
| Contact CSL Behring for facility details | |
| Omaha, Nebraska, United States, 69131 | |
| United States, Oklahoma | |
| Contact CSL Behring for facility details | |
| Tulsa, Oklahoma, United States, 74133 | |
| United States, Oregon | |
| Contact CSL Behring for facility details | |
| Eugene, Oregon, United States, 97401 | |
| United States, Pennsylvania | |
| Contact CSL Behring for facility details | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Dakota | |
| Contact CSL Behring for facility details | |
| Rapid City, South Dakota, United States, 57702 | |
| United States, Texas | |
| Contact CSL Behring for facility details | |
| Dallas, Texas, United States, 75230 | |
| Canada, Ontario | |
| Contact CSL Behring for facility details | |
| 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: | Global Head Clinical Research & Development, 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: | October 6, 2011 |
| 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 May 16, 2013