clinical trial · NCT06096116
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
Octapharma·phase3·recruiting·n = 120
Acquired Antithrombin DeficiencyHuman plasma derived antithrombinPlacebo
brief 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)
started
Aug 21, 2024
primary completion
Mar 1, 2028
completion
Mar 1, 2028
last updated
Feb 2, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol