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

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 |
- 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.
- 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.
- 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.
- 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.

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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 |
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

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
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 | |
Contact CSL Behring for facility details | |
Ottawa, Ontario, Canada, KIY 4G2 |
Study Director: | Program Director | CSL Behring |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |
C1 Inhibitor Hereditary angioedema Acute HAE attack |
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 |