Hereditary Angioedema (HAE) Clinical Trial
Official title:
A European Multi-Center, Multi-Country, Post-Authorisation, Observational Study (Registry) Of Patients With Hereditary Angioedema (HAE) Who Are Administered CINRYZE® (C1 Inhibitor [Human]) For The Treatment Or Prevention Of HAE Attacks
| Verified date | March 2021 |
| Source | Takeda |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 83 |
| Est. completion date | September 25, 2016 |
| Est. primary completion date | September 25, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria All patients must: - Have a diagnosis of HAE and be receiving CINRYZE for prevention or treatment of angioedema attacks - Provide written informed consent/assent in compliance with applicable country-specific and local regulations Exclusion Criteria All patients must not: - Be receiving CINRYZE in an investigational study - Be receiving another HAE therapy as part of a clinical trial |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Universitair Ziekenhuis Antwerpen (UZA) | Antwerp | Edegem |
| Belgium | Clinic St-Luc University Hospital | Brussels | |
| France | CHU d'Angers | Angers | |
| France | Hôpital Claude-Huriez | Lille | |
| France | Immunologie Clinique et Allergologie | Nancy | |
| France | Hôpital Saint Antoine | Paris | |
| France | Université Paris Descartes | Paris | |
| Germany | Allergie-Centrum-Charite | Berlin | |
| Germany | Universitätsklinik Essen | Essen | |
| Germany | Johann Wolfgang Goethe Universität | Frankfurt | |
| Germany | Universität-Hautklinik Mainz | Mainz | |
| Germany | Hämophilie-Zentrum Rhein Main | Mörfelden-Walldorf | |
| Germany | Klinikum rechts der Isar der technischen Universität München | München | |
| Italy | Ospedale Luigi Sacco | Milano | |
| Italy | Azienda Ospedaliera "V. Cervello" | Palermo | |
| Spain | C.A.R San Pedro | Logrono | |
| Spain | Hospital General Universitario | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| United Kingdom | Barts and the London NHS Trust | London | |
| United Kingdom | Northern General Hospital | Sheffield |
| Lead Sponsor | Collaborator |
|---|---|
| Shire |
Belgium, France, Germany, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of adverse drug reactions | 12 months | ||
| Primary | Incidence of thrombotic/thromboembolic events | 12 months | ||
| Primary | Occurrence of pregnancy | 12 months |
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