- Ongoing, recruitingTherapeutic confirmatory (Phase III)
A Phase 3 Open-label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema in Pediatric Subjects 2 to 11 Years of Age
This study is testing a new medicine, garadacimab, for children aged 2-11 with hereditary angioedema (HAE). It aims to see how safe the medicine is, how it moves through the body, and if it helps prevent HAE attacks. Researchers will also check for any side effects.
For: Hereditary angioedema (HAE)Germany · Italy - Ongoing, recruitingTherapeutic confirmatory (Phase III)
An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
This study looks at a new medicine called garadacimab for people with hereditary angioedema (HAE). It aims to see if the treatment is safe and helps prevent HAE attacks over a long time. Researchers are checking how many side effects people have and if attacks become less frequent.
For: Hereditary angioedemaNetherlands · Germany · Hungary - Ongoing, recruitingTherapeutic use (Phase IV)
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
This study looks at the safety of switching to a new medication called garadacimab for people aged 12 and over with Hereditary Angioedema (HAE). It aims to see how common side effects are after making the switch from their usual treatment.
For: Hereditary Angioedema (HAE)Germany - Active not recruitingPHASE4
Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
This study looks at how safe a medicine called garadacimab is for people aged 12 and over with hereditary angioedema (HAE). It checks if switching to garadacimab from their usual preventative HAE treatment is safe when given once a month for about three months.
For: Hereditary AngioedemaUnited States · Canada · Germany