Includes: Hereditary Angioedema
Conditions
Keywords
C1-esterase Inhibitor, Hereditary angioedema, Acute HAE attack
Brief summary
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.
Interventions
BIOLOGICALBerinert® (C1 Esterase Inhibitor)
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.
Sponsors
Chiltern International Inc.
CSL Behring
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of thrombotic and thrombo-embolic events | Within 30 days of treatment with Berinert® |
| Occurrence of suspected viral transmission | Duration of the study, at least 3 years |
| Use of concomitant medications and plasma products | Duration of the study, at least 3 years |
Countries
Denmark, Germany, Switzerland, United States
Outcome results
None listed