Trials / Completed
CompletedNCT04656418
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy and Safety of Subcutaneous Administration of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary angioedema.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CSL312 | Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody |
| DRUG | Placebo | Buffer without active ingredient |
Timeline
- Start date
- 2021-01-27
- Primary completion
- 2022-06-07
- Completion
- 2022-06-07
- First posted
- 2020-12-07
- Last updated
- 2023-06-29
- Results posted
- 2023-06-29
Locations
28 sites across 7 countries: United States, Canada, Germany, Hungary, Israel, Japan, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04656418. Inclusion in this directory is not an endorsement.