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Berinert P Study of Subcutaneous Versus Intravenous Administration

NCT00748202 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-01-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

C1-Esterase Inhibitor

1000 I.E.

Sponsors & Collaborators

  • Clinical trial center Rhine-Main

    collaborator UNKNOWN

  • ZKI Kindergerinnungslabor

    collaborator OTHER

  • Institut für Medizinische Virologie JWG-University hospital

    collaborator UNKNOWN

  • CSL Behring

    collaborator INDUSTRY

  • PharmaPart

    collaborator INDUSTRY

  • University of Milan

    collaborator OTHER

  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Wolfhart Kreuz, PD Phd · Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00748202 on ClinicalTrials.gov