According to a story from the National Hemophilia Foundation, the Swedish pharmaceutical company Orphan Biovitrum announced that its first patient was registered for a new phase 4 clinical trial. The trial is going to test the use of Eloctate as a part of immune tolerance induction therapy for hemophilia patients with inhibitors. Immune tolerance induction is meant eradicate inhibitors, which can cause the body to develop tolerance to a therapy after it has been introduced on a daily basis.
Hemophilia is a genetic disorder in which the body’s ability to heal blood clots is impaired. This process is an essential component of the healing process and allows the body to stop bleeding wounds on its own. Without this function, patients have an increased risk of internal bleeding inside the joints and the brain, will bleed for significantly longer after being wounded, and will bruise more easily. The condition is more common in males than females as it is linked to the x chromosome. The disease is treated by replacing the missing blood clotting factors, but some people develop antibodies to the clotting factor which can make treatment more difficult. To learn more about this disease, click here.
The trial is meant for testing with hemophilia A. In this type of hemophilia, the blood clotting factor VIII is missing. Eloctate is a factor VIII fusion protein. This treatment is meant to offer an advantage over other treatments because it is designed to keep the clotting factor circulating longer in the body, meaning that patients will not have to receive treatment as often. The treatment was first certified by the FDA in 2014. The process for finding more patients may be lengthy, as the trial is specifically looking for patients that have developed inhibitors to factor VIII that has caused other therapies to become less effective.