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June 3, 2016: Six-Year Study of Hemophilia Treatments in Toddler Patients Concludes

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After five years of research, a study, called the SIPPET (Survey of Inhibitors in Plasma-Products Exposed Toddlers), has released the first findings as to whether hemophilia treatments sourced from human plasma may be safer for hemophiliac toddlers than treatments sourced from genetic engineering.

What is Hemophilia?

Hemophilia is an inherited bleeding disorder characterized by the body’s inability to form blood clots. This occurs due to an absence or low levels of either factor VIII (referred to as hemophilia A) or factor IX (referred to as hemophilia B) clotting proteins that are found in the blood.

As a result, a person with hemophilia may experience spontaneous bleeding, or prolonged bleeding following an injury. The condition cannot be cured.

The severity of hemophilia is categorized as mild, moderate, or severe; and is based on the levels of clotting proteins found in a person’s blood. SIPPET study participants were diagnosed with severe, hemophilia A.

Why is SIPPET Testing Hemophilia Treatments?

Hemophilia is treated by intravenous injection of a commercially prepared clotting factor into the blood, resulting in proper blood clot formation. Referred to as “replacement therapy” this treatment relies primarily on plasma-derived factor concentrates (made from human plasma) and recombinant factor concentrates (genetically engineered through DNA technology.)

The five-year SIPPET study was designed to determine whether the factor VIII protein source, either plasma-derived or recombinant, would affect the rate of inhibitor formation in previously untreated patients under the age of six years with severe hemophilia.

What is Inhibitor Production?

The U.S. Centers for Disease Control and Prevention (CDC) approximates that 15 – 20 percent of people with hemophilia develop antibodies that inhibit clotting factor products from being able to clot blood and stop bleeding. These antibodies are referred to as “inhibitors” and make the treatment of a bleeding episode difficult.

According to the CDC, “People with inhibitors often experience more joint disease and other problems from bleeding that result in a reduced quality of life.”

What Has the SIPPET Study Found So Far?

The first results of the SIPPET study found that when severe hemophilia was treated with recombinant factor VIII (genetically engineered blood-clotting protein), the PUPs experienced an 87% higher incidence of inhibitor development than treatment with plasma-derived factor VIII (donated human blood-clotting protein).

According to leading researcher Prof. Peyvandi, the findings “may have implications for the choice of products to treat PUPs, since the development of inhibitors remains the major challenge in the management of hemophilia A”.

The final results of the SIPPET study will be published in 2016.

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