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news.ThromboGenics and BioInvent International have dosed first patient in a multicenter, double blind, randomized Phase IIb trial evaluating TB-402 (Anti-Factor VIII) for the prophylaxis of venous thromboembolism (VTE) following total hip surgery.
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The Phase IIb trial will compare the safety and efficacy of two dose levels of TB-402, given as a single intravenous infusion after hip surgery, with the recently approved Factor Xa inhibitor rivaroxaban.
ThromboGenics and BioInvent expect to unveil the results of the trial in the second half of 2012.
Earlier, the Phase IIa trial of TB-402 demonstrated positive results for VTE prophylaxis after knee replacement surgery, compared with enoxaparin.
ThromboGenics CEO Patrik De Haes said TB-402 has already shown the potential to significantly improve the treatment of VTE in the post-surgery setting.
"We hope that this study will confirm these promising results and give us a better understanding of the overall benefits that TB-402 can provide to this patient group," Haes said.