Hereditary Angioedema Clinical Trial
— PASSIONOfficial title:
Pharmacokinetics Berinert P Study of Subcutaneous Versus Intravenous Administration in Subjects With Moderate Hereditary Angioedema - The Passion Study
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 mode in cases where i.v. access is not suitable.
The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic
study.
Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert
P) and than switch to the treatment not administered before.
Status | Completed |
Enrollment | 24 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Germany | Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital | Frankfurt | Hessen |
Lead Sponsor | Collaborator |
---|---|
Johann Wolfgang Goethe University Hospitals | Clinical trial center Rhine-Main, CSL Behring, Institut für Medizinische Virologie JWG-University hospital, PharmaPart, University of Milan, ZKI Kindergerinnungslabor |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Individual courses of C1-inhibitor levels, from these will be derived pharmacokinetic parameters | i.v. and s.c.samples: 0, 0.25, 0.5, 0.75 hours and 1, 2, 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 120, 168, 336 an 504 hours. | No | |
Secondary | Safety of s.c. and i.v. administration of study medication | 2 years | Yes |
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