Hereditary Angioedema Clinical Trial
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
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.
| Status | Completed |
| Enrollment | 57 |
| Est. completion date | May 2010 |
| Est. primary completion date | February 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 6 Years and older |
| Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | Contact CSL Behring for facility details | Ottawa | Ontario |
| United States | Contact CSL Behring for facility details | Atlanta | Georgia |
| United States | Contact CSL Behring for facility details | Boston | Massachusetts |
| United States | Contact CSL Behring for facility details | Chicago | Illinois |
| United States | Contact CSL Behring for facility details | Dallas | Texas |
| United States | Contact CSL Behring for facility details | Eugene | Oregon |
| United States | Contact CSL Behring for facility details | Hershey | Pennsylvania |
| United States | Contact CSL Behring for facility details | Idaho Falls | Idaho |
| United States | Contact CSL Behring for facility details | Omaha | Nebraska |
| United States | Contact CSL Behring for facility details | Plymouth | Minnesota |
| United States | Contact CSL Behring for facility details | Rapid City | South Dakota |
| United States | Contact CSL Behring for facility details | Shreveport | Louisiana |
| United States | Contact CSL Behring for facility details | Tulsa | Oklahoma |
| United States | Contact CSL Behring for facility details | Weston | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| CSL Behring |
United States, Canada,
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. — View Citation
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. — View Citation
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 Angioedem — View Citation
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. — View Citation
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 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) | The start of symptom relief was determined by subject self-assessment. | Up to 24 h after start of study treatment | No |
| Primary | Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) | The start of symptom relief was determined by subject self-assessment. | Up to 24 h after start of study treatment | No |
| Secondary | Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) | Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card. | Up to Day 9 following an attack | No |
| Secondary | Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) | Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card. | Up to Day 9 following an attack | No |
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