An observational study in Hereditary Angioedema, sponsored by Pharming Technologies B.V.. Completed at 17 sites in 13 countries. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Pharming Technologies B.V. · Observational
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
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.
Exclusion Criteria:
Drug: rhC1INH or pdC1INH
C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)
Also known as: Ruconest
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
Time frame: December 2019
To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)
Time frame: December 2019
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Pharming Technologies B.V.