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
1 Sites
12 Participants
Recruiting
2 Years to 11 Years

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SUBMIT
Barzilai University Medical Center
Ashkelon,Israel,7830604

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

Additional studies can be found at ClinicalTrials.gov