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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

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

MedlinePlus Genetics related topics: Hereditary angioedema

Drug Information available for: SERPING1 protein, human

Genetic and Rare Diseases Information Center resources: Hereditary Angioedema

U.S. FDA Resources

Arms and Interventions

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

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 ]
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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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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

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

Additional Information:

United States Hereditary Angioedema Association This link exits the ClinicalTrials.gov site

Publications of Results:

Wasserman RL, Levy RJ, Bewtra AK, Hurewitz D, Craig TJ, Kiessling PC, Keinecke HO, Bernstein JA. Prospective study of C1 esterase inhibitor in the treatment of successive acute abdominal and facial hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2011 Jan;106(1):62-8. doi: 10.1016/j.anai.2010.10.012. Epub 2010 Nov 20.

Craig TJ, Bewtra AK, Bahna SL, Hurewitz D, Schneider LC, Levy RJ, Moy JN, Offenberger J, Jacobson KW, Yang WH, Eidelman F, Janss G, Packer FR, Rojavin MA, Machnig T, Keinecke HO, Wasserman RL. C1 esterase inhibitor concentrate in 1085 Hereditary Angioedema attacks--final results of the I.M.P.A.C.T.2 study. Allergy. 2011 Dec;66(12):1604-11. doi: 10.1111/j.1398-9995.2011.02702.x. Epub 2011 Sep 2.

Other Publications:

Craig TJ, Wasserman RL, Levy RJ, Bewtra AK, Schneider L, Packer F, Yang WH, Keinecke HO, Kiessling PC. Prospective study of rapid relief provided by C1 esterase inhibitor in emergency treatment of acute laryngeal attacks in hereditary angioedema. J Clin Immunol. 2010 Nov;30(6):823-9. doi: 10.1007/s10875-010-9442-1. Epub 2010 Jul 16.

Bernstein JA, Machnig T, Keinecke HO, Whelan GJ, Craig TJ. The effect of weight on the efficacy and safety of C1 esterase inhibitor concentrate for the treatment of acute hereditary angioedema. Clin Ther. 2014 Apr 1;36(4):518-25. doi: 10.1016/j.clinthera.2014.02.005. Epub 2014 Mar 21. Erratum in: Clin Ther. 2014 Jun 1;36(6):992.

Bork K, Craig TJ, Bernstein JA, Feuersenger H, Machnig T, Staubach P. Efficacy of C1 esterase inhibitor concentrate in treatment of cutaneous attacks of hereditary angioedema. Allergy Asthma Proc. 2015 May-Jun;36(3):218-24. doi: 10.2500/aap.2015.36.3844. Epub 2015 Mar 23.

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

Craig TJ, Rojavin MA, Machnig T, Keinecke HO, Bernstein JA. Effect of time to treatment on response to C1 esterase inhibitor concentrate for hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2013 Sep;111(3):211-5. doi: 10.1016/j.anai.2013.06.021. Epub 2013 Jul 16.

Craig TJ, Bewtra AK, Hurewitz D, Levy R, Janss G, Jacobson KW, Packer F, Bernstein JA, Rojavin MA, Machnig T, Keinecke HO, Wasserman RL. Treatment response after repeated administration of C1 esterase inhibitor for successive acute hereditary angioedema attacks. Allergy Asthma Proc. 2012 Jul-Aug;33(4):354-61. doi: 10.2500/aap.2012.33.3589.

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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 Genetic Diseases, Inborn Complement C1s Complement C1 Inhibitor Protein Complement C1 Inactivator Proteins Immunologic Factors Physiological Effects of Drugs Complement Inactivating Agents Immunosuppressive Agents

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