Includes: Hereditary Angioedema Clinical Trial
Official title:
Patient Registry for Berinert®, a C1-Esterase Inhibitor
| Verified date | June 2014 |
| Source | CSL Behring |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 318 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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® |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Denmark, Odense C | Odense C | |
| Germany | Germany, Berlin | Berlin | |
| Germany | Germany, Frankfurt | Frankfurt | |
| Germany | Germany, Mainz | Mainz | |
| Germany | Germany, München | München | |
| Switzerland | Switzerland, Luzern 16 | Luzern 16 | |
| United States | United States, Pennsylvania | Altoona | Pennsylvania |
| United States | United States, Georgia | Atlanta | Georgia |
| United States | United States, Massachusetts | Boston | Massachusetts |
| United States | United States, New Jersey | Branchburg | New Jersey |
| United States | United States, Ohio | Centerville | Ohio |
| United States | United States, Maryland | Chevy Chase | Maryland |
| United States | United States, Ohio | Cincinnati | Ohio |
| United States | United States, Maryland | Columbia | Maryland |
| United States | United States, South Carolina | Columbia | South Carolina |
| United States | United States, Texas | Dallas | Texas |
| United States | United States, North Carolina | Durham | North Carolina |
| United States | United States, New Jersey | Edison | New Jersey |
| United States | United States, California | Granada Hills | California |
| United States | United States, Pennsylvania | Hershey | Pennsylvania |
| United States | United States, Idaho | Idaho Falls | Idaho |
| United States | United States, New Jersey | Iselin | New Jersey |
| United States | United States, Missouri | Kansas City | Missouri |
| United States | United States, Oregon | Lake Oswego | Oregon |
| United States | United States, California | Los Angeles | California |
| United States | United States, Louisiana | New Orleans | Louisiana |
| United States | United States, New York | New York | New York |
| United States | United States, New York | North Syracuse | New York |
| United States | United States, New Jersey | Ocean | New Jersey |
| United States | United States, Oklahoma | Oklahoma City | Oklahoma |
| United States | United States, Pennsylvania | Pittsburgh | Pennsylvania |
| United States | United States, Minnesota | Plymouth | Minnesota |
| United States | United States, South Dakota | Rapid City | South Dakota |
| United States | United States, California | Redding | California |
| United States | United States, California | San Diego | California |
| United States | United States, Arizona | Scottsdale | Arizona |
| United States | United States, Washington | Spokane | Washington |
| United States | United States, Missouri | St. Louis | Missouri |
| United States | United States, Washington | Tacoma | Washington |
| United States | United States, Oklahoma | Tulsa | Oklahoma |
| Lead Sponsor | Collaborator |
|---|---|
| CSL Behring | Chiltern International Inc. |
United States, Denmark, Germany, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of thrombotic and thrombo-embolic events | Within 30 days of treatment with Berinert® | Yes | |
| Primary | Occurrence of suspected viral transmission | Duration of the study, at least 3 years | Yes | |
| Primary | Use of concomitant medications and plasma products | Duration of the study, at least 3 years | No |