Status:
COMPLETED
Berinert P Study of Subcutaneous Versus Intravenous Administration
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Collaborating Sponsors:
Clinical trial center Rhine-Main
ZKI Kindergerinnungslabor
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is performed to investigate the subcutaneous (s.c.) versus intravenous (i.v.) administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration m...
Detailed Description
Patients with hereditary angioedema (HAE), suffer from recurring and mostly unforeseeable attacks of acute oedema of subcutaneous tissues of various organs. The pathophysiological correlate of this di...
Eligibility Criteria
Inclusion
- Subjects with an established diagnosis of HAE type I (C1-Inhibitor activity \< 50% and C1-Inhibitor antigen \< 15.4 mg/dl) or HAE type II (C1-Inhibitor activity \< 50% and C1-Inhibitor antigen in normal or elevated concentration of dysfunctional protein).
- Male and female subjects with an age of at least 18 years.
- Subjects providing an informed consent.
Exclusion
- Subjects without an established diagnosis of HAE.
- Last C1-INH administration less than 7 days ago and/or acute attack.
- Subjects with acquired angioedema (AAE).
- All other types of angioedema not associated with C1-INH deficiency.
- Treatment with any investigational drug (exclusive drugs appropriate for the treatment of acute angioedema) 30 days before study treatment.
- Treatment with any other drug appropriate for the treatment of acute angioedema within 7 days before start of study treatment at each phase.
- Danazol prophylaxis.
- Prophylaxis with antifibrinolytics, EACA, tranexamic acid.
- Subjects with a known hypersensitivity to study medication (Berinert P).
- Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to breast-feed
- Subjects with malignant diseases.
- Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
- Subjects with concurrent serious or acute illness or infection as per investigators judgement.
- Subjects with mental conditions which render the subject or its legally acceptable representative unable to understand the nature, scope and possible consequences of the study.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00748202
Start Date
September 1 2008
End Date
December 1 2010
Last Update
January 19 2011
Active Locations (1)
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1
Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital
Frankfurt am Main, Hesse, Germany, 60590