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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
20 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 3
  • Use of C1-INH products, androgens, antifibrinolytics, approved or future approved medications, or other small molecule medications for routine prophylaxis against HAE attacks within a minimum of 2 weeks before the Treatment Period
  • Participation in another interventional clinical study during the 30 days before the Treatment Period or within 5 half-lives of the final dose of the investigational product administered during the previous interventional study, whichever is longer
  • Having laboratory clinical abnormalities assessed as clinically significant by the investigator in results of hematology or chemistry assessments performed during Screening
  • Currently receiving a therapy not permitted during the study
  • Being pregnant or breastfeeding.

Additional Studies

Additional studies can be found at