Trials / Recruiting
RecruitingNCT04918173
Efficacy of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
A Multicenter, Prospective, Open-label, Uncontrolled Phase 3 Study to Assess the Efficacy, Safety and Pharmacokinetics of Atenativ in Patients With Congenital Antithrombin Deficiency Undergoing Surgery or Delivery
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 38 (estimated)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 12 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to assess the incidence of the composite of thrombotic events (TEs) and thromboembolic events (TEEs) in patients with congenital antithrombin deficiency under when they receive Atenativ for surgical procedures or parturition.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atenativ | Antithrombin concentrate |
Timeline
- Start date
- 2022-07-01
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2021-06-08
- Last updated
- 2025-11-21
Locations
30 sites across 14 countries: United States, Armenia, Austria, Czechia, France, Georgia, Germany, Hungary, Israel, Italy, Romania, Serbia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04918173. Inclusion in this directory is not an endorsement.