Human pasteurized C1 esterase inhibitor concentrate (CE1145) in subjects with congenital C1-INH deficiency and acute abdominal or facial HAE attacksConcentrado de inhibidor C1 de esterasas humano y pasteurizado (CE1145) para sujetos con deficiencia congénita de C1-INH y ataques abdominales o faciales agudos del angioedema hereditario - C1-INH HAE study
- Conditions
- Hereditary angioedema (HAE) is characterized by congenital C1-INH deficiency. This is reflected by insufficient plasma concentrations of C1 – inhibitor or by synthesis of dysfunctional C1 – inhibitor molecules, which can lead to attacks of abdominal pain and/or severe swelling in the tissues e.g. of the face. Replacement with C1 esterase inhibitor concentrate is the treatment of choice of an acute attack of HAE.MedDRA version: 7.0Level: LLTClassification code 10019860
- Registration Number
- EUCTR2004-001186-17-ES
- Lead Sponsor
- ZLB Behring GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 126
- Male and female subjects >= 6 years
- Documented congenital C1-INH deficiency with functional or immunogenic C1-INH level and C4 antigen level below the lower limit of the local laboratory reference range (to be confirmed by central laboratory)
- Documented history of abdominal or facial attacks
- Acute moderate/severe abdominal or facial attack with a duration not longer than
5.0 hours at the time of study medication administration
- Informed written consent has been obtained (signed by subject, or, in case of a minor, by his/her legally acceptable representative(s))
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Life expectancy < 6 months
- Incurable malignancies with metastases
- History of hypersensitivity to the study medication
- Acquired angioedema (e. g., onset at age > 40 years and no family history, low C1q level, and no known HAE mutation)
- Abdominal pain caused by other pathology (e. g., appendicitis, myocardial infarction)
- End-stage liver disease (i.e., Child-Pugh-score B or C)
- HIV positive
- Fever (> 38.3°C or 101.0 F)
- High white blood cell count (> 20.0 x 109/L )
- Pregnant women (pregnancy test required), women currently breast-feeding, or with the intention to breast feed
- Treatment with any other investigational drug in the last 30 days before study entry
- Treatment with any C1-INH concentrate within the previous 7 days
- Treatment with fresh frozen plasma or native plasma within the previous 7 days
- Treatment with ACE inhibitors within the previous 4 weeks
- Narcotic pain medication and/or anti-emetics between start of attack and enrollment (signing of informed consent)
- Evidence of narcotic seeking behavior and/or drug addiction (including alcohol abuse)
- Mental condition rendering the subject (or the subject’s legally acceptable representative(s)) unable to understand the nature, scope and possible consequences of the study
- Prior inclusion into this study
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method