Phase
Condition
Hereditary Angioedema
Hives (Urticaria)
Urticaria
Treatment
N/AClinical Study ID
Ages > 13 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: Patients fulfilling the following criteria at Screening are eligible for participation inthe study:
Age 13 years or older
Laboratory confirmed diagnosis of HAE
A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3consecutive months).
Female patients of childbearing potential who are sexually active must be willing touse an acceptable form of contraception.
Provided written informed consent (and written assent for minors)
Willingness and ability to comply with all protocol procedures
Exclusion
Exclusion Criteria: Patients who meet any of the following criteria at Screening are to be excluded from studyparticipation:
Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
Diagnosis of acquired angioedema (AAE)
Patients who are pregnant, or breastfeeding, or are currently intending to becomepregnant
Treatment with any investigational drug in the past 30 days
Patients with any condition or treatment that, in the opinion of the Investigator,might interfere with the evaluation of study objectives
Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors
Study Design
Study Description
Connect with a study center
Ottawa Allergy Research Corp
Ottawa, Ontario K1G6C6
CanadaSite Not Available
Faculty Hospital by St. Anna Brno, Department of clinical Immunology and Allergology
Brno, 65691
CzechiaSite Not Available
Azienda Ospedaliera Universitaria Luigi Sacco Di Milano
Milan, 20157
ItalySite Not Available
PHI University Clinic of Dermatology
Skopje, 1000
Macedonia, The Former Yugoslav Republic ofSite Not Available
Pharming Technologies BV
Leiden, 233 CR
NetherlandsSite Not Available
SC Centrul Clinic Mediquest SRL
Singeorgiu de Mures, Mures 547530
RomaniaSite Not Available
SC Centrul Clinic Mediquest SRL
Sângeorgiu de Mureş, Mures 547530
RomaniaSite Not Available
Clinical Center Serbia
Belgrade,
SerbiaSite Not Available
University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida 33613
United StatesSite Not Available
University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida 33613
United StatesSite Not Available
Washington University Division of Allergy and Immunology
Saint Louis, Missouri 63141
United StatesSite Not Available
Washington University Division of Allergy and Immunology
St. Louis, Missouri 63141
United StatesSite Not Available
Baker Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon 97035
United StatesSite Not Available
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