A trial evaluating the efficacy and safety of BAY 86-6150 in people with hemophilia A and hemophilia B with inhibitors has been discontinued. The hope that BAY 86-6150 might help patients with inhibitors to achieve better control of their disease could not be fulfilled due to the detection of a neutralizing antibody in the trial.
The TRUST ( TReatment with Unique recombinant rFVIIa Study ) trial is a Phase II/III, multicenter, open-label clinical study designed to assess the safety and efficacy of BAY 86-6150, a recombinant factor VIIa ( rFVIIa ) protein, in patients with hemophilia A or B with inhibitors.
Hemophilia A, also known as factor VIII deficiency or classic hemophilia, is largely an inherited bleeding disorder in which one of the proteins needed to form blood clots in the body is missing or reduced. Hemophilia A is characterized by prolonged or spontaneous bleeding, especially into the muscles, joints, or internal organs.
Hemophilia B, also known as Christmas disease, is a less common type of hemophilia. People with hemophilia B have little or no factor IX.
Inhibitor development is a serious medical problem that can occur when a person with hemophilia has an immune response to treatment with clotting factor concentrates. About a third of hemophilia A patients develop inhibitors, with the development of inhibitors being more common in hemophilia A. ( Xagena )
Source: Bayer HealthCare, 2013