C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
NCT ID: NCT00292981
Last Updated: 2015-05-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
57 participants
INTERVENTIONAL
2005-08-31
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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C1 Esterase Inhibitor
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
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Acute HAE attack
* Participation in base study CE1145\_3001 (NCT00168103)
Exclusion Criteria
* Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry
6 Years
ALL
No
Sponsors
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CSL Behring
INDUSTRY
Responsible Party
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Principal Investigators
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Program Director
Role: STUDY_DIRECTOR
CSL Behring
Locations
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Weston, Florida, United States
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Atlanta, Georgia, United States
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Idaho Falls, Idaho, United States
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Chicago, Illinois, United States
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Shreveport, Louisiana, United States
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Boston, Massachusetts, United States
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Plymouth, Minnesota, United States
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Omaha, Nebraska, United States
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Tulsa, Oklahoma, United States
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Eugene, Oregon, United States
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Hershey, Pennsylvania, United States
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Rapid City, South Dakota, United States
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Dallas, Texas, United States
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Ottawa, Ontario, Canada
Countries
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References
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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.
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.
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.
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.
Related Links
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United States Hereditary Angioedema Association
Other Identifiers
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1453
Identifier Type: OTHER
Identifier Source: secondary_id
CE1145_3003
Identifier Type: -
Identifier Source: org_study_id
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