Berinert P Study of Subcutaneous Versus Intravenous Administration

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johann Wolfgang Goethe University Hospital
• Collaborators: Clinical trial center Rhine-Main; CSL Behring; Institut für Medizinische Virologie JWG-University hospital; PharmaPart; University of Milan; ZKI Kindergerinnungslabor
• Treatments: Complement C1 Inactivator Proteins; Complement C1 Inhibitor Protein; Complement C1s

Criteria

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.