Trials / Recruiting
RecruitingNCT06096116
Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Octapharma · Industry
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Human plasma derived antithrombin | A solvent/detergent and heat-treated antithrombin concentrate derived from human plasma |
| DRUG | Placebo | Half of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ |
Timeline
- Start date
- 2024-08-21
- Primary completion
- 2028-03-01
- Completion
- 2028-03-01
- First posted
- 2023-10-23
- Last updated
- 2026-02-02
Locations
24 sites across 9 countries: United States, Austria, Canada, Czechia, France, Lithuania, Romania, Slovenia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06096116. Inclusion in this directory is not an endorsement.