Clinical Trial: Patient Registry Study of Berinert® in Normal Clinical Practice
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: Patient Registry for Berinert®, a C1-Esterase Inhibitor
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.
Detailed Summary:
Sponsor: CSL Behring
Current Primary Outcome:
- 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 ]
Original Primary Outcome:
- 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, approximately 3 years ]
- Use of concomitant medications and plasma products [ Time Frame: Duration of the study, approximately 3 years ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: CSL Behring
Dates:
Date Received: April 12, 2010
Date Started: April 2010
Date Completion:
Last Updated: June 5, 2014
Last Verified: June 2014
