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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv
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Weston, Florida, United States
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Atlanta, Georgia, United States
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.
Time frame: Up to 24 h after start of study treatment
Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
The start of symptom relief was determined by subject self-assessment.
Time frame: Up to 24 h after start of study treatment
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.
Time frame: Up to Day 9 following an attack
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.
Time frame: Up to Day 9 following an attack
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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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
...and 4 more locations