- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01397864
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks
February 6, 2024 updated by: Pharming Technologies B.V.
C1 Inhibitor Treatment Registry to Assess the Safety and Immunological Profile of Ruconest in the Treatment of HAE Attacks
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
see below
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Miranda Boshuizen
- Phone Number: +31 71 5247 400
- Email: m.boshuizen@pharming.com
Study Locations
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Sofia, Bulgaria
- Recruiting
- UMHAT Alexandrovska EAD
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Contact:
- Maria Staevska, Prof.
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Split, Croatia
- Recruiting
- KBC Split
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Contact:
- Drasko Cikojevic, Dr.
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Zagreb, Croatia
- Recruiting
- CHC Sestre milosrdnice
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Contact:
- Renata Vrsalovic, Dr.
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Šibenik, Croatia
- Recruiting
- General Hospital Sibenik
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Contact:
- Ljerka Karadza-Lapic, Dr.
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Brno, Czechia
- Recruiting
- Faculty Hospital by St. Anna Brno
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Contact:
- Roman Hakl, Dr.
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La Tronche, France
- Recruiting
- Hospital A Michallon, CHU Grenoble
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Contact:
- Laurence Bouillet, Prof. Dr.
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Berlin, Germany
- Recruiting
- Charite Universitatsmedizin Berlin
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Contact:
- Marcus Maurer, Prof.
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Contact:
- Markus Magerl, Dr.
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Budapest, Hungary
- Recruiting
- Semmelweis University, 3rd Department of Internal Medicine
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Contact:
- Henriette Farkas, Prof.
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Milan, Italy
- Recruiting
- Ospedale Luigi Sacco
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Contact:
- Andrea Zanichelli, Dr.
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Skopje, North Macedonia
- Recruiting
- PHI University Clinic of Dermatology
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Contact:
- Vesna Grivcheva-Panovska, Prof.
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Alesund, Norway
- Completed
- Alesund Hospital
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Stavanger, Norway
- Completed
- Stavanger University Hospital
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Krakow, Poland
- Completed
- University Hospital Krakow
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Bratislava, Slovakia
- Recruiting
- Bratislava University Hospital
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Contact:
- Katarina Hrubiskova, Dr.
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Martin, Slovakia
- Recruiting
- University Hospital Martin
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Contact:
- Milos Jesenak, Prof.
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Golnik, Slovenia
- Completed
- University Clinic Golnik
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Jonkoping, Sweden
- Completed
- Ryhof County Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
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.
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Hereditary Angioedema
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C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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December 2019
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)
Time Frame: December 2019
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December 2019
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anurag Relan, MD, Pharming Technologies BV
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2011
Primary Completion (Estimated)
January 1, 2025
Study Completion (Estimated)
January 1, 2025
Study Registration Dates
First Submitted
July 18, 2011
First Submitted That Met QC Criteria
July 19, 2011
First Posted (Estimated)
July 20, 2011
Study Record Updates
Last Update Posted (Actual)
February 7, 2024
Last Update Submitted That Met QC Criteria
February 6, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Skin Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Hypersensitivity, Immediate
- Genetic Diseases, Inborn
- Skin Diseases, Vascular
- Hypersensitivity
- Urticaria
- Hereditary Complement Deficiency Diseases
- Primary Immunodeficiency Diseases
- Angioedema
- Angioedemas, Hereditary
Other Study ID Numbers
- C1 1412
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hereditary Angioedema
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Pharvaris Netherlands B.V.Active, not recruitingHereditary Angioedema | Hereditary Angioedema Type I | Hereditary Angioedema Type II | Hereditary Angioedema Types I and II | Hereditary Angioedema Attack | Hereditary Angioedema With C1 Esterase Inhibitor Deficiency | Hereditary Angioedema - Type 1 | Hereditary Angioedema - Type 2 | C1 Esterase Inhibitor... and other conditionsUnited States, Poland, Germany, Austria, Bulgaria, Canada, Ireland, Italy, United Kingdom
-
Pharvaris Netherlands B.V.CompletedHereditary Angioedema | Hereditary Angioedema Type I | Hereditary Angioedema Type II | Hereditary Angioedema Types I and II | Hereditary Angioedema Attack | Hereditary Angioedema With C1 Esterase Inhibitor Deficiency | Hereditary Angioedema - Type 1 | Hereditary Angioedema - Type 2 | C1 Esterase Inhibitor... and other conditionsBulgaria, United States, Spain, Israel, Germany, Canada, Czechia, France, Hungary, Italy, Netherlands, Poland, United Kingdom
-
Pharvaris Netherlands B.V.RecruitingHereditary Angioedema | Hereditary Angioedema Type I | Hereditary Angioedema Type II | Hereditary Angioedema Types I and II | Hereditary Angioedema Attack | Hereditary Angioedema With C1 Esterase Inhibitor Deficiency | Hereditary Angioedema - Type 1 | Hereditary Angioedema - Type 2 | C1 Esterase Inhibitor... and other conditionsUnited States
-
Pharvaris Netherlands B.V.RecruitingHereditary Angioedema | Hereditary Angioedema Type I | Hereditary Angioedema Type II | Hereditary Angioedema Types I and II | Hereditary Angioedema Attack | Hereditary Angioedema With C1 Esterase Inhibitor Deficiency | Hereditary Angioedema - Type 1 | Hereditary Angioedema - Type 2 | C1 Esterase Inhibitor... and other conditionsUnited States, Bulgaria, Czechia, Hungary, Spain, France, Germany, Poland, Canada, Israel
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CENTOGENE GmbH RostockCompletedHereditary Angioedema | Hereditary Angioedema Type I | Hereditary Angioedema Type II | C1 Esterase Inhibitor Deficiency | HAE | Angio Edema | C4 Deficiency | Hereditary Angioedema Type IIITurkey, Armenia, Georgia, India, Peru, Poland, Romania
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HAE Global Registry FoundationRecruitingHereditary Angioedema Type I and IIItaly
-
KalVista Pharmaceuticals, Ltd.CompletedHereditary AngioedemaUnited States, Austria, Czechia, Germany, Hungary, Italy, Netherlands, North Macedonia, Poland, United Kingdom
-
Prothya BiosolutionsCompletedHereditary Angioedema Type I | Angioneurotic EdemaNetherlands
-
TakedaNot yet recruitingHereditary Angioedema (HAE)
-
CSL BehringRecruitingHereditary Angioedema (HAE)United States, Israel
Clinical Trials on rhC1INH or pdC1INH
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Pharming Technologies B.V.US Hereditary Angioedema AssociationCompleted
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Pharming Technologies B.V.CompletedHereditary AngioedemaUnited States, Bulgaria, Canada, Hungary, Israel, Italy, Macedonia, The Former Yugoslav Republic of, Poland, Romania, Serbia, South Africa
-
Pharming Technologies B.V.CompletedHereditary AngioedemaIsrael, Italy, United States, Czechia, Germany, Hungary, Poland, Romania, Slovakia, North Macedonia
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University of Wisconsin, MadisonPharming Technologies B.V.UnknownKidney FailureUnited States
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Pharming Technologies B.V.CompletedGenetic DisordersNetherlands
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Pharming Technologies B.V.CompletedHereditary Angioedema | Genetic DisordersNetherlands, Romania
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Pharming Technologies B.V.CompletedHereditary AngioedemaUnited States, Canada, Czechia, Italy, Macedonia, The Former Yugoslav Republic of, Romania, Serbia
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Hospital Ambroise Paré ParisCompletedLumbar RadiculopathyFrance
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Samjin Pharmaceutical Co., Ltd.Completed
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Pharming Technologies B.V.CompletedHereditary Angioedema | Angioneurotic EdemaNetherlands