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This is a non-interventional treatment Registry of Hereditary Angioedema (HAE) patients treated with C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.
see below
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hereditary Angioedema |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhC1INH or pdC1INH | Drug | C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INH of acute angioedema attacks | December 2019 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies) | December 2019 |
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Inclusion Criteria:
Exclusion Criteria:
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The aim is to recruit 300 patients treated with Ruconest. Additionally, the study will continue until 100 patients have been exposed to Ruconest for at least 3 attacks. Enrolment in the pdC1INH arm will be unrestricted.
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| Name | Affiliation | Role |
|---|---|---|
| Anurag Relan, MD | Pharming Technologies BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMHAT Alexandrovska EAD | Sofia | Bulgaria | ||||
| KBC Split |
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| Split |
| Croatia |
| General Hospital Sibenik | Šibenik | Croatia |
| CHC Sestre milosrdnice | Zagreb | Croatia |
| Faculty Hospital by St. Anna Brno | Brno | Czechia |
| Hospital A Michallon, CHU Grenoble | La Tronche | France |
| Charite Universitatsmedizin Berlin | Berlin | Germany |
| Semmelweis University, 3rd Department of Internal Medicine | Budapest | Hungary |
| Ospedale Luigi Sacco | Milan | Italy |
| PHI University Clinic of Dermatology | Skopje | North Macedonia |
| Alesund Hospital | Ålesund | Norway |
| Stavanger University Hospital | Stavanger | Norway |
| University Hospital Krakow | Krakow | Poland |
| Bratislava University Hospital | Bratislava | Slovakia |
| University Hospital Martin | Martin | Slovakia |
| University Clinic Golnik | Golnik | Slovenia |
| Ryhof County Hospital | Jönköping | Sweden |
| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| D000799 | Angioedema |
| ID | Term |
|---|---|
| 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 |
|---|---|
| C571093 | conestat alfa |
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