Patient Registry Study of Berinert® in Normal Clinical Practice

Completed

• Conditions: Includes: Hereditary Angioedema
• Interventions: Biological: Berinert® (C1 Esterase Inhibitor)

• 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

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-04-12
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-05
• Last Update Posted: 2014-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 318

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Berinert	Berinert® (C1 Esterase Inhibitor)	Patients requiring treatment with Berinert®

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

Trial Locations

Locations (26)

United States, New York; 🇺🇸 North Syracuse, New York, United States

United States, Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

United States, Washington; 🇺🇸 Tacoma, Washington, United States

United States, Oregon; 🇺🇸 Lake Oswego, Oregon, United States

United States, Missouri; 🇺🇸 St. Louis, Missouri, United States

Germany, Berlin; 🇩🇪 Berlin, Germany

United States, Maryland; 🇺🇸 Columbia, Maryland, United States

Germany, Mainz; 🇩🇪 Mainz, Germany

United States, Texas; 🇺🇸 Dallas, Texas, United States

Germany, München; 🇩🇪 München, Germany

United States, Minnesota; 🇺🇸 Plymouth, Minnesota, United States

United States, Pennsylvania; 🇺🇸 Pittsburgh, Pennsylvania, United States

Germany, Frankfurt; 🇩🇪 Frankfurt, Germany

United States, Louisiana; 🇺🇸 New Orleans, Louisiana, United States

Denmark, Odense C; 🇩🇰 Odense C, Denmark

United States, California; 🇺🇸 San Diego, California, United States

United States, Massachusetts; 🇺🇸 Boston, Massachusetts, United States

United States, North Carolina; 🇺🇸 Durham, North Carolina, United States

United States, Ohio; 🇺🇸 Cincinnati, Ohio, United States

United States, Georgia; 🇺🇸 Atlanta, Georgia, United States

United States, Idaho; 🇺🇸 Idaho Falls, Idaho, United States

United States, New Jersey; 🇺🇸 Ocean, New Jersey, United States

United States, Arizona; 🇺🇸 Scottsdale, Arizona, United States

United States, South Dakota; 🇺🇸 Rapid City, South Dakota, United States

United States, South Carolina; 🇺🇸 Columbia, South Carolina, United States

Switzerland, Luzern 16; 🇨🇭 Luzern 16, Switzerland