Patient Registry Study of Berinert® in Normal Clinical Practice
- Conditions
- Includes: Hereditary Angioedema
- Registration Number
- NCT01108848
- Lead Sponsor
- CSL Behring
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- Any patient receiving CSL Behring's C1-esterase inhibitor
- Written informed consent (may not be required for some retrospective chart review cases)
- Any patient participating in an HAE study using other C1-inhibitors than Berinert®
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
United States, Arizona
🇺🇸Scottsdale, Arizona, United States
United States, California
🇺🇸San Diego, California, United States
United States, Georgia
🇺🇸Atlanta, Georgia, United States
United States, Idaho
🇺🇸Idaho Falls, Idaho, United States
United States, Louisiana
🇺🇸New Orleans, Louisiana, United States
United States, Maryland
🇺🇸Columbia, Maryland, United States
United States, Massachusetts
🇺🇸Boston, Massachusetts, United States
United States, Minnesota
🇺🇸Plymouth, Minnesota, United States
United States, Missouri
🇺🇸St. Louis, Missouri, United States
United States, New Jersey
🇺🇸Ocean, New Jersey, United States
Scroll for more (16 remaining)United States, Arizona🇺🇸Scottsdale, Arizona, United States