Berinert P Study of Subcutaneous Versus Intravenous Administration
Status:
Completed
Trial end date:
2010-12-01
Target enrollment:
Participant gender:
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
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