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| Name | Class |
|---|---|
| US Hereditary Angioedema Association | UNKNOWN |
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This is a prospective, real-world, observational patient registry for patients with HAE who are receiving treatment with Ruconest for HAE.
See below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hereditary Angioedema | Patients with Hereditary Angioedema who are receiving treatment with Ruconest (rhC1INH). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rhC1INH | Drug | Recombinant human C1 inhibitor |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety analysis will consist of AEs reported per patient for up to 30 days after each single or repeated dose of Ruconest. | In addition, extent of exposure to Ruconest and concomitant medications taken for HAE will be summarized. Concomitant medications will be limited to those specifically indicated for treatment AEs or treatment of symptoms of HAE, for example C1-inhibitors, epinephrine, IV fluids, etc. AEs will be summarized as incidence per 10,000 person-days where each patient counts only once for multiple events of the same System Organ Class and preferred terms within the 30-day evaluation period. The person-time duration for each AE for each patient is the time period (in days) between the dose of Ruconest and AE onset. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| AEs occurring during pregnancy or lactation and for breastfed infants will be summarized separately using the same methods as described in the primary outcome measure. | Any pregnant woman who treats with Ruconest while on the Registry will be followed up to twelve weeks post-delivery or termination. Those treated with Ruconest while actively nursing will be followed until end of lactation. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
1. Patient is receiving HAE therapy as part of a clinical trial.
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Eligible patients will be 13 years of age and older, have a current diagnosis of HAE for which they have been prescribed and are currently being treated with Ruconest.
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| Name | Affiliation | Role |
|---|---|---|
| Anurag Relan, MD | Pharming Technologies BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The US Hereditary Angioedema Association | Fairfax | Virginia | 22030 | United States |
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| ID | Term |
|---|---|
| D054179 | Angioedemas, Hereditary |
| ID | Term |
|---|---|
| D000799 | Angioedema |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000081208 | Hereditary Complement Deficiency Diseases |
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| ID | Term |
|---|---|
| C571093 | conestat alfa |
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| 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 |