HELSINKI, Finland, March 15, 2012 /PRNewswire/ -- CSL Behring
announced today that the first patient has been treated as part of
the REPLACE Phase III clinical trial evaluating the efficacy and
safety of fibrinogen concentrate (Human) (FCH) in controlling
microvascular bleeding during aortic aneurysm surgery.
The purpose of this study is to demonstrate that Fibrinogen
Concentrate (Human)(FCH) can reduce intraoperative bleeding and,
therefore, the volume 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 study will also aim to show that FCH is safe and well
tolerated. The primary efficacy endpoint measurement will be the
number of units of all allogeneic blood products transfused during
the first 24 hours after administration of FCH or
placebo.
"Potentially life-threatening bleeding events can occur during
cardiovascular surgery because the patient's fibrinogen levels are
depleted, which delays clotting," said Dr. Niels Rahe-Meyer, Department of Anesthesiology
and Intensive Care, Franziskus Hospital, Bielefeld, Germany and coordinating investigator of
the study. "The REPLACE Phase III study will help determine if FCH
treatment can safely reduce the number of transfusions needed
during cardiovascular surgery. If this is the case, we will have a
powerful new option for use in protecting cardiovascular surgery
patients from potentially life-threatening bleeding and
transfusion-associated adverse events and discomfort."
Of the 12 million units of blood used in the United States each year, 15 percent are
used in cardiovascular surgery. Studies have shown that blood
transfusion during or after adult cardiac surgery is associated
with increased long-term mortality.
"As a global leader in the development of plasma-derived and
recombinant coagulation factors for bleeding disorders, we are
pleased that this important Phase III study of FCH in aortic
aneurysm surgery is underway," said Russell
Basser, M.D., Senior Vice President, Global Clinical
R&D. "CSL Behring is committed to exploring the use of FCH in
patients at high risk of bleeding resulting from cardiac surgery
and providing optimal, uncompromised therapy to cardiac surgery
teams and patients."
About the REPLACE Study
REPLACE (Randomized evaluation of fibrinogen versus placebo in
complex cardiovascular surgery) is a Phase III, prospective,
multinational, multicenter, randomized, double-blind,
placebo-controlled, two-arm study. Patients undergoing elective
thoracic aortic surgery are randomized in a 1:1 ratio to treatment
with FCH or placebo. Patients will receive a single intra-operative
infusion if their blood loss amounts to 60 to 250g in 5 minutes
after initial surgery is completed. Following infusion, a second
5-minute bleeding mass measurement is undertaken. If blood loss
then still amounts to 60 g or more, the patient will be treated
according to a predefined, standardized treatment regimen using
allogeneic blood products. Reduction of allogenic blood products
and other efficacy endpoints in addition to safety endpoints will
be measured according to the trial protocol. For more information
visit www.clinicaltrials.gov and search with identifier:
NCT01475669.
About Fibrinogen and Fibrinogen Concentrate
Fibrinogen, also called Factor I, is a protein needed to form
blood clots and, thereby, to stop bleeding. Fibrinogen levels in
plasma determine the potential clotting ability and activity in the
body. Diminished concentrations of fibrinogen limit the body's
ability to form a clot and increase the risk of uncontrolled
bleeding. A simple blood test can detect the level of fibrinogen;
the normal range is 2-4 grams per liter. In patients undergoing
cardiopulmonary bypass surgery, the plasma concentration of
fibrinogen has been reported to decrease by 34 to 42 percent, which
can increase the risk of post-operative bleeding. During
manufacture, CSL Behring's purified, pasteurized, fibrinogen
concentrate undergoes multiple steps to remove potential pathogens,
including being heated in aqueous solution at 60 degrees
centigrade/140 degrees Fahrenheit for 20 hours. A publication by
the World Federation of Hemophilia provides additional perspective
on this matter. Fibrinogen concentrate is mostly tolerated without
undesirable reactions. In rare cases allergoid-anaphylactoid
reactions (like generalized urticaria, rash, fall in blood
pressure, dyspnoea), and/or rise in temperature are observed. If
allergoid-anaphylactoid reactions occur, the administration of
fibrinogen concentrate has to be discontinued immediately (e.g. by
interruption of the injection/infusion) and an appropriate
treatment has to be initiated. The current medical standards for
shock treatment are to be observed. There is a potential risk of
thromboembolic episodes (including myocardial infarction and
pulmonary embolism) following the administration of human plasma
fibrinogen concentrate.
Standard measures to prevent infections resulting from the use
of medicinal products prepared from human blood or plasma include
selection of donors, screening of individual donations and plasma
pools for specific markers of infection and the inclusion of
effective manufacturing steps for the inactivation/removal of
viruses. Despite this, when medicinal products prepared from human
blood or plasma are administered, the possibility of transmitting
infective agents cannot be totally excluded. This also applies to
unknown or emerging viruses and other pathogens. The measures taken
are considered effective for enveloped viruses such as HIV, HBV and
HCV. These measures may possibly be of limited value against
non-enveloped viruses such as HAV and parvovirus B19.
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 indicated for the
treatment of coagulation disorders including hemophilia and von
Willebrand disease, primary immune deficiencies, hereditary
angioedema and inherited respiratory disease. The company's
products are also used in cardiac surgery, organ transplantation,
burn treatment and to prevent hemolytic diseases in newborns. CSL
Behring operates one of the world's largest plasma collection
networks, CSL Plasma. CSL Behring is a subsidiary of CSL
Limited (ASX: CSL), a biopharmaceutical company headquartered
in Melbourne, Australia. For more
information, visit www.cslbehring.com.
Media Contact:
Sheila A. Burke, Director,
Communications & Public Relations
Worldwide Commercial Operations
CSL Behring
610-878-4209 (o)
484-919-2618 (c)
Sheila.Burke@cslbehring.com
Etanjalie Ayala
Weber Shandwick
212-445-8225
eayala@webershandwick.com
SOURCE CSL Behring