PORTOLA BEGINS OF PHASE II TRIAL OF FACTOR XA INHIBITOR
Portola Pharmaceuticals announced that it has initiated a Phase II clinical trial with its oral Factor Xa inhibitor for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing knee replacement surgery.
The multicenter, randomized, active-control study will evaluate the safety and efficacy of Portola's compound compared to Lovenox (enoxaparin sodium injection), a current standard of care for the prevention of DVT and PE, following knee replacement surgery. Relative safety and efficacy will be evaluated, with the primary efficacy endpoint defined as the absence of PE or DVT as determined by venogram. The study will be conducted at 20 sites in the United States and Canada.