Trials / Completed
CompletedNCT03712228
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- CSL Behring · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Factor XIIa antagonist monoclonal antibody | Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use |
| DRUG | Placebo | Buffer without active ingredient |
Timeline
- Start date
- 2018-10-29
- Primary completion
- 2021-10-15
- Completion
- 2021-10-15
- First posted
- 2018-10-19
- Last updated
- 2022-11-08
- Results posted
- 2022-11-08
Locations
16 sites across 5 countries: United States, Australia, Canada, Germany, Israel
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03712228. Inclusion in this directory is not an endorsement.