CSL Behring announced today that the last patient has been treated as part of the REPLACE (Randomized Evaluation of fibrinogen versus PLACEbo in complex cardiovascular surgery) Phase III clinical trial. REPLACE is the first randomized, double blinded, placebo-controlled, multicenter study in a large population of patients evaluating fibrinogen concentrate (Human) (FCH) in controlling bleeding during aortic aneurysm surgery.
The REPLACE study was designed to demonstrate the safety, efficacy and tolerability of fibrinogen concentrate in reducing intraoperative bleeding and the amount of donor blood products (e.g., fresh frozen plasma, platelets and red blood cells) needed during complex cardiovascular surgical procedures such as aortic aneurysm surgery. The primary efficacy endpoint measured the total number of units of allogeneic blood products transfused during the first 24 hours after administration of FCH or placebo.
"Given the limitations of current treatment options, new safe and effective therapies are important for protecting cardiovascular surgery patients from severe bleeding and transfusion-associated adverse events," said Dr. Niels Rahe-Meyer, Professor and Head of the Department of Anesthesiology and Intensive Care, Franziskus Hospital, Bielefeld, Germany and coordinating investigator of the study. "We look forward to analyzing our findings from the REPLACE Phase III study to determine if FCH treatment can safely and effectively reduce the number of transfusions needed during cardiovascular surgery."
Timely and effective hemostatic management is important in cardiovascular surgery because the use of allogeneic blood transfusion can worsen clinical outcomes. In particular, studies have shown that blood transfusion during, or after, adult cardiovascular surgery is associated with increased long-term mortality.
"At CSL Behring, we are committed to improving the lives of people with serious health conditions by continuously working to address unmet medical needs with novel therapies,” said Charmaine Gittleson, Senior Vice President of Clinical Research and Development, CSL Behring. "This is a significant milestone in the study of fibrinogen concentrate and it brings us one step closer to providing an important treatment option to operating teams and their patients who are experiencing a bleed."
About the REPLACE Study
REPLACE is a Phase III, prospective, multinational, multicenter, randomized, double-blind, placebo-controlled, two-arm study. Patients undergoing elective aortic surgery were randomized in a 1:1 ratio to treatment with FCH or placebo.
Five minutes after surgical haemostasis was completed, patients received a single intra-operative infusion of fibrinogen concentrate or placebo if their blood loss amounted to between 60 and 250 g. If blood loss of 60 g or more continued ten minutes after the administration of study medication was completed, the patient was treated according to a predefined, standardized treatment regimen using allogeneic blood products.
The REPLACE study follows CSL Behring’s Phase II prospective study, performed by the company and collaborators at the Hannover Medical School, Germany. Results from the Phase II study suggest proactive, targeted treatment with fibrinogen concentrate may safely reduce the need for transfusions and restore clotting ability in patients undergoing aortic surgery.
For more information about the REPLACE study, visit http://www.clinicaltrials.gov and search with identifier: NCT01475669.
About Fibrinogen and Fibrinogen Concentrate
Fibrinogen, also called Factor I, is a protein needed for blood clotting and for stopping bleeding. Diminished concentrations of fibrinogen limit the body's ability to support clotting at the wound area and increase the risk of bleeding. In patients who undergo major surgery, such as aortic surgery, fibrinogen concentration and subsequently clot strength, decrease during the operation. Correcting the levels of fibrinogen in these patients is critical in controlling bleeding.
CSL Behring’s fibrinogen concentrate has more than 25 years of global clinical use. The company’s Integrated Safety System helps ensure its fibrinogen concentrate meets high quality and safety standards for virus inactivation and reduction. The processes involved in the manufacture of CSL plasma-derived products meet the highest regulatory standards for purity, safety and quality.
About CSL Behring
CSL Behring is a leader in the plasma protein therapeutics industry. Committed to saving lives and improving the quality of life for people with rare and serious diseases, the company manufactures and markets a range of plasma-derived and recombinant therapies worldwide.
CSL Behring therapies are used around the world to treat coagulation disorders including hemophilia and von Willebrand disease, primary immune deficiencies, hereditary angioedema and inherited respiratory disease, and neurological disorders in certain markets. The company’s products are also used in cardiac surgery, organ transplantation, burn treatment and to prevent hemolytic diseases in the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. CSL Behring is a global biopharmaceutical company and a member of the CSL Group of companies. The parent company, CSL Limited (ASX:CSL), is headquartered in Melbourne, Australia. For more information, visit http://www.cslbehring.com/.