Trials / Completed
CompletedNCT05819775
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 2 Years – 11 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL312 | Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously (SC) |
Timeline
- Start date
- 2023-05-30
- Primary completion
- 2025-11-19
- Completion
- 2025-11-19
- First posted
- 2023-04-19
- Last updated
- 2026-01-26
Locations
13 sites across 5 countries: United States, Australia, Canada, Germany, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05819775. Inclusion in this directory is not an endorsement.