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| ID | Type | Description | Link |
|---|---|---|---|
| SHP616-401 |
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This observational (non-interventional) study is being conducted to characterize the safety and use of CINRYZE in routine clinical practice when administered for (1) routine prevention of angioedema attacks, (2) pre-procedure prevention of angioedema attacks, and/or (3) treatment of angioedema attacks.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions | 12 months | |
| Incidence of thrombotic/thromboembolic events | 12 months | |
| Occurrence of pregnancy | 12 months |
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Inclusion Criteria
All patients must:
Exclusion Criteria
All patients must not:
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Patients with HAE in Europe who are receiving CINRYZE in routine clinical practice for prevention or treatment of angioedema attacks. Approximately 20 sites are planned for enrollment.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Antwerpen (UZA) | Antwerp | Edegem | 2650 | Belgium | ||
| Clinic St-Luc University Hospital |
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| Label | URL |
|---|---|
| To obtain more information on the study, click here/on this link. | View source |
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| Brussels |
| Belgium |
| CHU d'Angers | Angers | 49033 | France |
| Hôpital Claude-Huriez | Lille | 59037 | France |
| Immunologie Clinique et Allergologie | Nancy | 54500 | France |
| Hôpital Saint Antoine | Paris | 75571 | France |
| Université Paris Descartes | Paris | 75679 | France |
| Allergie-Centrum-Charite | Berlin | 10117 | Germany |
| Universitätsklinik Essen | Essen | 45122 | Germany |
| Johann Wolfgang Goethe Universität | Frankfurt | 60590 | Germany |
| Universität-Hautklinik Mainz | Mainz | 55131 | Germany |
| Hämophilie-Zentrum Rhein Main | Mörfelden-Walldorf | D-64546 | Germany |
| Klinikum rechts der Isar der technischen Universität München | München | 81675 | Germany |
| Ospedale Luigi Sacco | Milan | 20157 | Italy |
| Azienda Ospedaliera "V. Cervello" | Palermo | 90146 | Italy |
| C.A.R San Pedro | Logroño | 26003 | Spain |
| Hospital General Universitario | Madrid | 28007 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Barts and the London NHS Trust | London | E1 2ES | United Kingdom |
| Northern General Hospital | Sheffield | S5 7AU | United Kingdom |
| 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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