A Phase 4 Open-label Study to Evaluate the Safety After Switching to CSL312 (Garadacimab) From Current Prophylactic HAE Treatment in Subjects With HAE ≥ 12 Years of Age
CSL Behring
Summary
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * • Aged \>= 12 years at the time of providing written informed consent / assent. * • Have a history of response to on-demand HAE treatment for the treatment of acute HAE attacks. * • Documented laboratory diagnosis in medical records of C1-esterase inhibitor hereditary angioedema (HAE-C1INH) type 1 or type 2: * ◦ Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria), * ◦ C1-esterase inhibitor (C1INH) antigen concentration or functional activity less than (\<) 50% of normal as documented in t…
Interventions
- BiologicalGaradacimab
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.
Locations (11)
- Research Solutions of ArizonaLitchfield Park, Arizona
- Allergy and Asthma Clinic of Northwest ArkansasBentonville, Arkansas
- Donald Levy M.D.Orange, California
- Raffi Tachdjian MD, Inc.Santa Monica, California
- Bernstein Clinical Research Center, LLCCincinnati, Ohio
- Chronicle BioWest Valley City, Utah