The efficacy and safety of Octaplex has been demonstrated in both congenital and acquired coagulation factor deficiencies. In the clinical trials, not only the recovery but also the half-life of the measured factors lay within the normal range. Thrombotic events, historically reported in connection with the use of prothrombin complex concentrates (PCC) have not been reported with Octaplex. Furthermore, seroconversions and immunogenic reactions have not occured. Octaplex effectively stopped bleeding. The mean dosages used in the clinical trials for achieving clear efficacy, and the number of treatment days necessary for completion of treatment, were both in the lower ranges of those normally required for the treatment of such patients.

Virus inactivation is achieved with Solvent/Detergent treatment - the gold standard for the rapid and highly effective inactivation of lipid coated viruses. Non enveloped viruses are also efficiently reduced by nanofiltration. Together, the in vitro characterisation, the virus validation studies and the clinical studies have revealed Octaplex to be a safe and efficacious PCC preparation. Added heparin and traces of ATIII contribute further to the safety of Octaplex against thrombosis by preventing factor activation on reconstitution.