Hereditary Angioedema Clinical Trial
Official title:
C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks
| NCT number | NCT01397864 |
| Other study ID # | C1 1412 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 2011 |
| Est. completion date | January 2025 |
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.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | January 2025 |
| Est. primary completion date | January 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | Inclusion Criteria: - Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH) - Patients must give written informed consent Exclusion Criteria: - A diagnosis of acquired C1INH deficiency (AAE) |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | UMHAT Alexandrovska EAD | Sofia | |
| Croatia | General Hospital Sibenik | Šibenik | |
| Croatia | KBC Split | Split | |
| Croatia | CHC Sestre milosrdnice | Zagreb | |
| Czechia | Faculty Hospital by St. Anna Brno | Brno | |
| France | Hospital A Michallon, CHU Grenoble | La Tronche | |
| Germany | Charite Universitatsmedizin Berlin | Berlin | |
| Hungary | Semmelweis University, 3rd Department of Internal Medicine | Budapest | |
| Italy | Ospedale Luigi Sacco | Milan | |
| North Macedonia | PHI University Clinic of Dermatology | Skopje | |
| Norway | Alesund Hospital | Alesund | |
| Norway | Stavanger University Hospital | Stavanger | |
| Poland | University Hospital Krakow | Krakow | |
| Slovakia | Bratislava University Hospital | Bratislava | |
| Slovakia | University Hospital Martin | Martin | |
| Slovenia | University Clinic Golnik | Golnik | |
| Sweden | Ryhof County Hospital | Jonkoping |
| Lead Sponsor | Collaborator |
|---|---|
| Pharming Technologies B.V. |
Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, North Macedonia, Norway, Poland, Slovakia, Slovenia, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | ||
| Secondary | To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies) | December 2019 |
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