C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks
C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks
1 other identifier
observational
181
11 countries
14
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 (rhC1INH / Ruconest), to observe adverse events and insufficient efficacy, and to assess the immunological profile following single and repeated treatment with Ruconest.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2011
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2024
CompletedApril 8, 2025
April 1, 2025
13.3 years
July 18, 2011
April 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)
December 2019
Study Arms (1)
Hereditary Angioedema
Interventions
C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)
Eligibility Criteria
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.
You may qualify if:
- Decision to treat the HAE patient with C1 inhibitor (either Ruconest or pdC1INH)
- Patients must give written informed consent
You may not qualify if:
- A diagnosis of acquired C1INH deficiency (AAE)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
UMHAT Alexandrovska EAD
Sofia, Bulgaria
KBC Split
Split, Croatia
General Hospital Sibenik
Šibenik, Croatia
CHC Sestre milosrdnice
Zagreb, Croatia
Faculty Hospital by St. Anna Brno
Brno, Czechia
Hospital A Michallon, CHU Grenoble
La Tronche, France
Charite Universitatsmedizin Berlin
Berlin, Germany
Semmelweis University, 3rd Department of Internal Medicine
Budapest, Hungary
Ospedale Luigi Sacco
Milan, Italy
PHI University Clinic of Dermatology
Skopje, North Macedonia
Alesund Hospital
Ålesund, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital Krakow
Krakow, Poland
Bratislava University Hospital
Bratislava, Slovakia
University Hospital Martin
Martin, Slovakia
University Clinic Golnik
Golnik, Slovenia
Ryhof County Hospital
Jönköping, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anurag Relan, MD
Pharming Technologies BV
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 20, 2011
Study Start
July 1, 2011
Primary Completion
October 18, 2024
Study Completion
December 10, 2024
Last Updated
April 8, 2025
Record last verified: 2025-04