Octapharma USA Sponsors NHF Conference, Unveils New VWD Clinical Trials Focused on Prophylactic Treatment and Pregnancy10-07-2019
HOBOKEN, N.J. (October 4, 2019) – Octapharma USA is sponsoring the National Hemophilia Foundation’s (NHF) 71st Bleeding Disorders Conference and introducing two new clinical trials focused on von Willebrand Disease (VWD). The clinical trials are featured in poster presentations at the NHF meeting being held in Anaheim, California through Saturday.
One clinical study will assess the efficacy and safety of WILATE® during prophylaxis in previously treated patients with VWD. This study has the primary objective to determine the efficacy of von Willebrand Factor (VWF)/Factor VIII (FVIIII) concentrate (WILATE®) in the prophylactic treatment of previously treated patients with type 3, type 2 (except 2N), or severe type 1 VWD.
“Prophylactic treatment in other congenital bleeding disorders is widely accepted as the standard of care to prevent bleeding and preserve quality of life in patients,” said Octapharma USA President Flemming Nielsen. “This form of treatment in VWD is not well characterized prospectively as yet. This study is intended to provide data on the efficacy of prophylactic treatment in reducing the rate of bleeding and on the impact of prophylaxis on the quality of life in VWD patients.”
Affecting approximately 1 percent of the population, VWD is a common inherited bleeding disorder that occurs when the blood lacks a protein that helps clotting. Type 3 VWD is the rarest and most severe form of the condition, representing approximately 5% of cases, according to the National Organization for Rare Disorders.
The second clinical trial, von Willebrand Factor in Pregnancy (VIP), is a multicenter study of WILATE® use in VWD for childbirth. The primary objective is to evaluate the:
· Rate of primary postpartum hemorrhage;
· Effectiveness of targeting VWF/FVIII minimum levels of 100% to 150% for delivery; and
· Effectiveness of targeting the immediate 72-hour postpartum period in pregnant patients with VWD whose third trimester factor levels are less than 100%, while aiming to maintain 50% to 100% target levels after the immediate postpartum period for the first 5 to 7 days postpartum after normal vaginal delivery or the first 7 to 10 days postpartum after caesarean section.
For pregnant women with VWD who by the third trimester do not have VWF or FVIII levels greater than 50% to 100%, specific guidance is lacking for delivery planning in terms of how high a factor level should be achieved. Specifically, guidance is lacking on whether replacement therapy should target a VWF minimum level in the 100% to 150% range, for example, or a range closer to the 200% to 250% levels observed in normal pregnancy.
Octapharma is currently recruiting study sites for both clinical trials. For complete details on the WILATE® prophylaxis study, please visit here (ClinicalTrials.gov Identifier: NCT04052698).
Octapharma encourages attendees to visit its NHF conference booth (#23) for research details and product-specific information.
WILATE®, von Willebrand Factor/Coagulation Factor VIII Complex (Human) Lyophilized Powder for Solution for Intravenous Injection, is indicated in children and adults with von Willebrand disease for on-demand treatment and control of bleeding episodes; and perioperative management of bleeding. WILATE® is indicated in adolescents and adults with hemophilia A for routine prophylaxis to reduce the frequency of bleeding episodes; and on-demand treatment and control of bleeding episodes. For complete prescribing information, please visit wilateusa.com.
Do not use in patients with known hypersensitivity reactions, including anaphylactic or severe systemic reaction, to human plasma-derived products, any ingredient in the formulation, or components of the container.
WARNINGS AND PRECAUTIONS
Anaphylaxis and severe hypersensitivity reactions are possible; thromboembolic events may occur; monitor plasma levels of FVIII activity; development of neutralizing antibodies to FVIII and to VWF, especially in VWD type 3 patients, may occur; WILATE® is made from human plasma and carries the risk of transmitting infectious agents.
About the Octapharma Group
Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma employs approximately 8,314 people worldwide to support the treatment of patients in over 115 countries with products across the following therapeutic areas: Hematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. The company’s American subsidiary, Octapharma USA, is located in Hoboken, N.J. Octapharma operates three state-of-the-art production sites licensed by the U.S. Food and Drug Administration (FDA), providing a high level of production flexibility. For more information, please visit www.octapharmausa.com.
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