Patient Registry Study of Berinert® in Normal Clinical Practice

The objective of this patient registry is to collect data on the safety of Berinert® in normal clinical practice in the United States. The patient registry will be maintained for a period of at least 3 years. The duration of individual patient participation will vary and is determined by the frequency of hereditary angioedema (HAE) attacks and the patient's need for Berinert® treatment.

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Key information

Conditions

Includes: Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Denmark, Odense C, Odense C, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Any patient receiving CSL Behring's C1-esterase inhibitor
Written informed consent (may not be required for some retrospective chart review cases)

Exclusion criteria

Any patient participating in an HAE study using other C1-inhibitors than Berinert®

Treatment and study plan

Berinert® (C1 Esterase Inhibitor)

Biological

Berinert® is marketed as a lyophilized concentrate available in a single-use vial to be reconstituted with sterile water before administration as described in the prescribing information.

Other names: C1-INH, Berinert P, CE1145

Primary outcomes

Incidence of thrombotic and thrombo-embolic events

Time frame: Within 30 days of treatment with Berinert®
Occurrence of suspected viral transmission

Time frame: Duration of the study, at least 3 years
Use of concomitant medications and plasma products

Time frame: Duration of the study, at least 3 years

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Collaborators

Chiltern International Inc.

Registry information

Official study title

Patient Registry for Berinert®, a C1-Esterase Inhibitor

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Apr 22, 2010
Registry last updated: Jun 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed