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| ID | Type | Description | Link |
|---|---|---|---|
| 1500 | Other Identifier | CSL Behring |
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| Name | Class |
|---|---|
| Chiltern International Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Berinert | Patients requiring treatment with Berinert® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Berinert® (C1 Esterase Inhibitor) | Biological | 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. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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An attempt will be made to prospectively identify patients and enroll them into this registry before treatment is required. In addition, retrospective chart/case review and data collection may be conducted.
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Program Director | CSL Behring | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, Arizona | Scottsdale | Arizona | 85251 | United States | ||
| United States, California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27699634 | Derived | Bygum A, Martinez-Saguer I, Bas M, Rosch J, Edelman J, Rojavin M, Williams-Herman D; Berinert Registry Investigators. Use of a C1 Inhibitor Concentrate in Adults >/=65 Years of Age with Hereditary Angioedema: Findings from the International Berinert(R) (C1-INH) Registry. Drugs Aging. 2016 Nov;33(11):819-827. doi: 10.1007/s40266-016-0403-0. | |
| 25609333 |
| Label | URL |
|---|---|
| Hereditary Angioedema Association (HAEA) | View source |
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|
| Granada Hills |
| California |
| 91344 |
| United States |
| United States, California | Los Angeles | California | 90095 | United States |
| United States, California | Redding | California | 96003 | United States |
| United States, California | San Diego | California | 92093 | United States |
| United States, Georgia | Atlanta | Georgia | 30342 | United States |
| United States, Idaho | Idaho Falls | Idaho | 83404 | United States |
| United States, Louisiana | New Orleans | Louisiana | 70118 | United States |
| United States, Maryland | Chevy Chase | Maryland | 20815 | United States |
| United States, Maryland | Columbia | Maryland | 21044 | United States |
| United States, Massachusetts | Boston | Massachusetts | 02115 | United States |
| United States, Minnesota | Plymouth | Minnesota | 55446 | United States |
| United States, Missouri | Kansas City | Missouri | 64108 | United States |
| United States, Missouri | St Louis | Missouri | 63110 | United States |
| United States, New Jersey | Branchburg | New Jersey | 08876 | United States |
| United States, New Jersey | Edison | New Jersey | 88220 | United States |
| United States, New Jersey | Iselin | New Jersey | 08830 | United States |
| United States, New Jersey | Ocean City | New Jersey | 07712 | United States |
| United States, New York | New York | New York | 10029 | United States |
| United States, New York | North Syracuse | New York | 13212 | United States |
| United States, North Carolina | Durham | North Carolina | 27710 | United States |
| United States, Ohio | Centerville | Ohio | 45458 | United States |
| United States, Ohio | Cincinnati | Ohio | 45267 | United States |
| United States, Oklahoma | Oklahoma City | Oklahoma | 73131 | United States |
| United States, Oklahoma | Tulsa | Oklahoma | 74133 | United States |
| United States, Oregon | Lake Oswego | Oregon | 97035 | United States |
| United States, Pennsylvania | Altoona | Pennsylvania | 16601 | United States |
| United States, Pennsylvania | Hershey | Pennsylvania | 17033 | United States |
| United States, Pennsylvania | Pittsburgh | Pennsylvania | 15213 | United States |
| United States, South Carolina | Columbia | South Carolina | 29203 | United States |
| United States, South Dakota | Rapid City | South Dakota | 57702 | United States |
| United States, Texas | Dallas | Texas | 75231 | United States |
| United States, Washington | Spokane | Washington | 99204 | United States |
| United States, Washington | Tacoma | Washington | 98405 | United States |
| Denmark, Odense C | Odense C | 5000 | Denmark |
| Germany, Mainz | Mainz | Germany | 55101 | Germany |
| Germany, Berlin | Berlin | 10117 | Germany |
| Germany, Frankfurt | Frankfurt | 60596 | Germany |
| Germany, München | München | 81675 | Germany |
| Switzerland, Luzern 16 | Lucerne | CH-6000 | Switzerland |
| Busse P, Bygum A, Edelman J, Lumry W, Machnig T, Martinez-Saguer I, Rojavin M. Safety of C1-esterase inhibitor in acute and prophylactic therapy of hereditary angioedema: findings from the ongoing international Berinert patient registry. J Allergy Clin Immunol Pract. 2015 Mar-Apr;3(2):213-9. doi: 10.1016/j.jaip.2014.08.014. Epub 2014 Oct 29. |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
| D000081207 | Primary Immunodeficiency Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D007153 | Immunologic Deficiency Syndromes |
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| ID | Term |
|---|---|
| D050718 | Complement C1 Inhibitor Protein |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D003174 | Complement C1 Inactivator Proteins |
| D015843 | Serpins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003169 | Complement Inactivator Proteins |
| D003165 | Complement System Proteins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
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