CSL Behring Provides $1.2M Grant for World's First Study of Postpartum Women with VWD
KING OF PRUSSIA, Pa., Aug. 18 /PRNewswire/ -- CSL Behring is providing a $1.2 million grant to fund a first-of-its kind, nationwide study that when completed could serve as the basis for determining optimal prophylaxis treatment for postpartum women with von Willebrand disease (VWD). Investigators anticipate that the study results will produce a better understanding of the physiology of VWD in the postpartum period, whether treatment is needed and, if so, for how long.
Von Willebrand disease (VWD) is the most common hereditary bleeding disorder in the United States, and is caused by a deficiency or abnormality of von Willebrand factor in the blood. According to the U.S. Centers for Disease Control (CDC), von Willebrand disease affects 1 to 2 percent of Americans -- as many as 2.8 million people -- more than half of whom are women. VWD occurs in males and females. Women, though, may suffer severe health consequences, such as life-threatening bleeding following childbirth, if their condition is not correctly diagnosed and managed. The National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH) and the U.S. Department of Health and Human Services, recently issued the first clinical guidelines in the U.S. for the diagnosis and treatment of VWD, citing issues specific to women, such as labor and delivery, as an ongoing research need and opportunity. For more information on the guidelines go to www.nhlbi.nih.gov/guidelines/vwd/index.htm.
"As a leader in the development of coagulation therapies, CSL Behring is committed to improving the quality of life for people with rare and serious diseases," said Robert Lefebvre, General Manager and Vice President of U.S. Commercial Operations at CSL Behring. "We hope that CSL Behring's support of this groundbreaking study will enable researchers to produce results that clinicians around the world can use in treating women who have VWD after they give birth."
In all women, von Willebrand factor (VWF) and factor VIII (FVIII) levels increase throughout the third trimester and then decrease to baseline within one month postpartum. There is anecdotal evidence that in women with VWD, this physiologic postpartum decrease in VWF and FVIII levels can be excessive, with their levels reaching even lower than their normal baseline, placing them at a much higher risk of postpartum hemorrhage. The new NHLBI guidelines state that because coagulation factors return to pre-pregnancy levels within 14-21 days, health care providers should be in close contact with women during this period.
"While we know that decreasing VWF levels following childbirth can result in serious complications for women with VWD there are very little clinical data available to guide physicians in treating these patients," said Peter Kouides, MD, a principal investigator of the study and Medical and Research Director of the Mary M. Gooley Hemophilia Center in Rochester, NY, one of the five sites where the study will be conducted. "By studying the patterns in declining VWF levels, we hope to learn whether treatment following birth is needed and the optimum duration of therapy."
The grant will be shared among Duke University Medical Center in Durham, North Carolina, the Mary M. Gooley Hemophilia Center in Rochester, New York, Robert Wood Johnson University Hospital in New Brunswick, New Jersey and two additional study sites. Andra James, MD, of Duke University Medical Center will serve as the study's principal investigator.
Study Design
This prospective cohort study will compare changes in blood levels of von Willebrand factor proteins postpartum between 40 women with and 40 women without VWD. At periodic intervals in the immediate postpartum period, von Willebrand Factor: Ristocetin cofactor activity (VWF:RiCoF), factor VIII (FVIII) and von Willebrand factor antigen (VWF:Ag) levels will be measured. The study will seek to determine how quickly, to what levels, and for how long VWF levels decline in the days after delivery. The study will also determine how postpartum bleeding in women with VWD correlates with VWF levels.
About von Willebrand Disease
Von Willebrand disease is caused by a deficiency or abnormality of the von Willebrand factor, a protein in the blood that is necessary for normal blood clotting. Men and women are equally likely to be affected by VWD. VWD is classified by types, ranging from Type I (the most common and mild) to Type III (the most severe).
Women with VWD are more likely to experience heavy, prolonged menstruation. Other common symptoms of VWD include frequent nosebleeds and easy bruising. Bleeding can be mild or serious and can occur as a result of injury, or without any obvious cause. More serious symptoms include bleeding into joints and internal organs. The VWD patient may require special care during dental procedures, surgery and childbirth.
Treatments for VWD may include desmopressin acetate to release von Willebrand factor the patient has stored in their cells; von Willebrand factor replacement therapies, and oral contraceptives to reduce menstrual bleeding and raise von Willebrand factor in the bloodstream. Antifibrinolytic therapies are also used successfully to treat menorrhagia.
About CSL Behring
CSL Behring is a global leader in the plasma protein biotherapeutics industry. Passionate about improving the quality of patients' lives, CSL Behring manufactures and markets a range of safe and effective plasma-derived and recombinant products and related services. The company's therapies are used in the treatment of immune deficiency disorders, hemophilia, von Willebrand disease, other bleeding disorders and inherited emphysema. Products include Humate P(R) Antihemophilic Factor/von Willebrand Factor Complex (Human) Dried, Pasteurized, for the treatment of von Willebrand Disease, and Helixate(R) FS a recombinant factor VIII treatment for hemophilia A. Other products are used for the prevention of hemolytic diseases in the newborn, in cardiac surgery, organ transplantation and in the treatment of burns. The company also operates one of the world's largest plasma collection networks, ZLB Plasma. CSL Behring is a subsidiary of CSL Limited, a biopharmaceutical company with headquarters in Melbourne, Australia. For more information, visit www.cslbehring.com.
CONTACT: Sheila A. Burke, Director, Communications & Public Relations,
Worldwide Commercial Operations, CSL Behring, +1-610-878-4209,
Sheila.Burke@cslbehring.com
Web site: http://www.cslbehring.com/
http://www.nhlbi.nih.gov/guidelines/vwd/index.htm/