BERLIN, Germany I May 3, 2013 I Bayer HealthCare today announced that a Phase II/III 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.
“Patient safety is our primary concern when designing clinical trials and evaluating BAY 86-6150,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “Due to safety concerns, we are discontinuing the BAY 86-6150 trial as a precautionary measure.”
About the Phase II/III 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.
About Hemophilia A, Hemophilia B, and 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, the most common type of hemophilia, is caused by a deficient or defective blood coagulation protein, known as factor VIII. 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.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare Pharmaceuticals
Post Views: 121
BERLIN, Germany I May 3, 2013 I Bayer HealthCare today announced that a Phase II/III 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.
“Patient safety is our primary concern when designing clinical trials and evaluating BAY 86-6150,” said Kemal Malik, MD, member of the Bayer HealthCare Executive Committee and Head of Global Development. “Due to safety concerns, we are discontinuing the BAY 86-6150 trial as a precautionary measure.”
About the Phase II/III 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.
About Hemophilia A, Hemophilia B, and 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, the most common type of hemophilia, is caused by a deficient or defective blood coagulation protein, known as factor VIII. 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.
About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 18.6 billion (2012), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,300 employees (Dec 31, 2012) and is represented in more than 100 countries. More information at www.healthcare.bayer.com.
SOURCE: Bayer HealthCare Pharmaceuticals
Post Views: 121
