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Hereditary Angioedema (HAE)

CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
NCT05819775 | Phase 3 | Interventional

The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.

Trial Information
6 Sites
12 Participants
2 Years to 11 Years

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Research Solutions of Arizona
Litchfield Park,Arizona,United States,85340
Medical Research of Arizona
Scottsdale,Arizona,United States,85251
Donald S. Levy M.D.
Orange,California,United States,92868
Raffi Tachdjian MD, Inc.
Santa Monica,California,United States,90404
Bernstein Clinical Research
Cincinnati,Ohio,United States,45236
Barzilai University Medical Center

Study Eligibility Criteria

  • Male or female
  • Aged 2 to 11 years, inclusive, with body weight ≥ 10th percentile based on age
  • Diagnosed with clinically confirmed C1-INH HAE
  • Experienced ≥ 2 HAE attacks during the 6 months before Screening
  • Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria, or HAE type III
  • Any preplanned major surgeries or procedures during the clinical study
  • Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks
  • Participation in another interventional clinical study

Additional Studies

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