ThromboGenics and BioInvent have completed the enrolment of 632-patient Phase IIb trial with anticoagulant TB-402 (factor VIII inhibitor) for the prophylaxis of venous thromboembolism (VTE) after total hip surgery.
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The trial has recruited patients from 36 centers across Europe.
This double blind trial is comparing two doses of TB-402 (25mg and 50mg), given as a single intravenous infusion after total hip replacement, with the r factor Xa inhibitor rivaroxaban.
TB-402 partially inhibits factor VIII, a key component of the coagulation cascade.
ThromboGenics CEO Patrik De Haes said that VTE remains a significant unmet need in many clinical settings despite the introduction of a number of new anticoagulants.