This study is designed to evaluate the safety after switching to garadacimab from another prophylactic hereditary angioedema (HAE) treatment (marketed kallikrein \[KK\] inhibitor or plasma-derived C1-esterase inhibitor \[pdC1INH\]prophylactic) when administered once monthly for approximately 3 months in participants aged greater than or equal to (\>=) 12 years with HAE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
18
Participants will receive a loading dose of garadacimab, followed by once monthly garadacimab administration for 2 months. Garadacimab will be given as a subcutaneous injection. The timing for the administration of the loading dose (first administration of garadacimab) is determined by the dosing schedule of the current HAE prophylactic treatment. No washout necessary.
Research Solutions of Arizona
Litchfield Park, Arizona, United States
Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States
Donald Levy M.D.
Orange, California, United States
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to Day 95 (End of study [EoS])
Percentage of Participants With TEAEs
Time frame: Up to Day 95 (EoS)
Number of TEAEs
Time frame: Up to Day 95 (EoS)
Rate of TEAEs per injection
Time frame: Up to Day 95 (EoS)
Rate of TEAEs per participant year
Time frame: Up to Day 95 (EoS)
Number of Participants With: Serious Adverse Events (SAEs), Deaths, Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and Adverse Events of Special Interest (AESI)
The AESIs for garadacimab are severe hypersensitivity including anaphylaxis.
Time frame: Up to Day 95 (EoS)
Percentage of Participants With: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI
Time frame: Up to Day 95 (EoS)
Number of SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, AESI and Laboratory Findings Reported as an AE, and AESI
Time frame: Up to Day 95 (EoS)
Rate per injection of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI
Time frame: Up to Day 95 (EoS)
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Raffi Tachdjian MD, Inc.
Santa Monica, California, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States
Chronicle Bio
West Valley City, Utah, United States
McMaster University-Hamilton
Hamilton, Ontario, Canada
Montreal Clinical Research Institute
Montreal, Quebec, Canada
Clinique Spécialisée en Allergie de la Capitale
Québec, Canada
HZRM Hämophilie Zentrum Rhein Main GmbH
Frankfurt, Germany
...and 1 more locations
Rate per participant year of: SAEs, Deaths, Treatment Related TEAEs, TEAEs leading to study discontinuation, TEAEs by severity, Laboratory Findings Reported as an AE, and AESI
Time frame: Up to Day 95 (EoS)
Number of Participants with Anti-garadacimab Antibodies
Time frame: Up to Day 95 (EoS)
Percentage of Participants with Anti-garadacimab Antibodies
Time frame: Up to Day 95 (EoS)
Plasma Concentrations of Garadacimab
Time frame: Up to Day 95 (EoS)
Percentage of Participants who Indicated Their Preference for Garadacimab
Time frame: Up to Day 95 (EoS)