Clinical Trial: C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks
Brief Summary: 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 (Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.
Detailed Summary: see below
Sponsor: Pharming Technologies B.V.
Current Primary Outcome: The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INHof acute angioedema attacks [ Time Frame: 3 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome: To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies) [ Time Frame: 3 years ]
Original Secondary Outcome: Same as current
Information By: Pharming Technologies B.V.
Dates:
Date Received: July 18, 2011
Date Started: July 2011
Date Completion: March 2018
Last Updated: October 14, 2016
Last Verified: October 2016