Navigation Links
CSL Behring Data Shows 4-Factor Prothrombin Complex Concentrate Is As Effective and a More Rapid Treatment for Vitamin K Antagonist Reversal Than Current Standard of Care
Date:5/4/2012

CHICAGO, May 4, 2012 /PRNewswire/ -- Data presented today by CSL Behring at the 2012 Thrombosis and Hemostasis Summit of North America (THSNA) showed that a balanced, human 4-factor prothrombin complex concentrate (PCC) is as effective as the current standard of treatment in stopping bleeding in patients receiving vitamin K antagonist therapy (i.e., warfarin). Currently in the United States, fresh frozen plasma is the standard treatment for warfarin reversal. The data are from the first and largest randomized clinical study to demonstrate the non-inferiority of 4-factor PCC to plasma through clinical endpoints and to show superiority through bioanalytical endpoints.  

The Phase IIIb study results showed that the hemostatic efficacy of 4-factor PCC was comparable to plasma at 24 hours in patients who required urgent reversal of warfarin therapy (72.4 percent and 65.4 percent, respectively). Additionally, the co-primary efficacy endpoint analysis showed that the 4-factor PCC was superior in achieving target INR correction within 30 minutes at the end of infusion as compared to plasma (62.2 percent and 9.6 percent, respectively). Four-factor PCC was also superior to plasma in rapidly and safely raising the levels of clotting factors II, VII, IX, X, and anticoagulant Proteins C and S at the same 30 minutes post-treatment time point (p values<0.0001).

"Patients on warfarin therapy are susceptible to acute and serious bleeding. For the physician, quickly stopping that bleeding is absolutely critical," said Ravindra Sarode, M.D., Director of Transfusion Medicine and Hemostasis Reference Laboratory at the University of Texas, Southwestern Medical Center, who presented the data. "This trial demonstrates that 4-factor PCC may offer healthcare professionals an important new treatment advance over plasma in managing patient outcomes in an important critical care setting."

The study also found that PCC was well-tolerated in patients and that the incidences of severe treatment-emergent adverse events, serious adverse events and deaths were generally similar between the PCC and plasma groups. Also, PCC was shown to possibly reduce the risk of transfusion-associated circulatory overload – that is, when too much fluid is transfused or transfusion is too rapid, which can lead to cardiac events – when compared to plasma (8.7 percent compared to 19.3 percent, respectively).

"We are very encouraged by the results, as this is the first and largest randomized clinical study showing 4-factor PCC is highly effective in reducing INR and increasing factor levels to support hemostatic efficacy during warfarin-induced bleeding," said Russell Basser, M.D., Senior Vice President, Global Clinical R&D, at CSL Behring. "CSL Behring is advancing our investigational 4-factor PCC through rigorous clinical study with the goal of bringing to the United States a safe, effective new treatment option for people who are at risk of major bleeding that results from warfarin use."

About Prothrombin Complex Concentrate (PCC) (Human)

Prothrombin complex concentrates (PCC) are derived from human plasma. CSL Behring's investigational PCC contains four important pro-coagulant factors in significant quantities: Factor II (prothrombin), Factor VII, Factor IX and Factor X, as well as anticoagulant Proteins C and S.

Guidelines from the American College of Chest Physicians recommend 4-factor PCC, rather than plasma, for rapid reversal of anticoagulation in patients with vitamin K antagonist associated major bleeding. The guidelines also recommend the use of vitamin K (5 to 10 mg) administered by slow intravenous (IV) infusion rather than reversal with coagulation factors alone.

About the Study

This was an open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of human 4-factor prothrombin complex concentrate (PCC) to plasma for rapid reversal of acute major bleeding in patients receiving warfarin therapy. The study enrolled 212 patients. The primary endpoint was hemostatic efficacy with respect to the adequacy of stopping an ongoing major bleed within 24 hours from the start of infusion. The secondary endpoints evaluated plasma levels of major clotting factors (Factors II, VII, IX, X, proteins C and S); time to INR correction; number of transfusions, amount of blood products used, and hemostatic agents; and safety and tolerability (including all-cause mortality).

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 Contacts:

Greg Healy
Senior Manager, Public Relations & Communications
CSL Behring
1-610-878-4841
greg.healy@cslbehring.com

Etanjalie Ayala
Weber Shandwick
212-445-8225
eayala@webershandwick.com


'/>"/>
SOURCE CSL Behring
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. CSL Behring Study Confirms Early Treatment with Berinert® Provides Faster Resolution of Acute Hereditary Angioedema Symptoms
2. Medical Experts Who Participated in CSL Behrings Key Issues Dialogue Prefer Albumin for Fluid Management
3. CSL Behring Awards LEAD Grant to Patient Organizations to Educate Constituents on State Insurance Exchanges
4. Overview of CSL Behring Innovations in Recombinant Technologies Presented at International Conference
5. CSL Behring Marks World Hemophilia Day by Announcing the Winners of the CSL Behring - Prof. Heimburger Award 2011
6. CSL Behring Awards Advocacy Grants to Patient Groups in Maryland, New England, the Midwest and Washington
7. ProFibrix and CSL Behring Enter Into Fibrinogen and Thrombin Supply Agreement
8. CSL Behrings Innovative HeliTrax(SM) System Helps Physicians Manage Hemophilia A Patients
9. Video: CSL Behring Provides $1.2M Grant for Worlds First Study of Postpartum Women with VWD, Common Bleeding Disorder
10. New Revolutionary Femoral Access Site Closure Device Shows Unparalleled Efficacy, Safety & Ease of Use, in a Wide Range of Patients Including Patients With a Challenging Anatomy
11. Pharmacoeconomic Analysis Shows SURFAXIN® May Reduce Hospital Cost Associated with Reintubation in Premature Infants
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... ... 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers use ... 6000i models are higher end machines that use the more unconventional z-dimension of 20mm. ... from the bottom of the cuvette holder. , FireflySci has developed several Agilent ...
(Date:6/23/2016)... , June 23, 2016 /PRNewswire/ - FACIT ... Ontario biotechnology company, Propellon Therapeutics ... development and commercialization of a portfolio of first-in-class ... Epigenetic targets such as WDR5 represent an exciting ... significantly in precision medicine for cancer patients. Substantial ...
(Date:6/23/2016)... , June, 23, 2016  The Biodesign Challenge (BDC), ... new ways to harness living systems and biotechnology, announced ... (MoMA) in New York City . ... participating students, showcased projects at MoMA,s Celeste Bartos Theater ... Antonelli , MoMA,s senior curator of architecture and design, ...
(Date:6/23/2016)... June 23, 2016 Apellis Pharmaceuticals, Inc. ... clinical trials of its complement C3 inhibitor, APL-2. ... multiple ascending dose studies designed to assess the ... subcutaneous injection in healthy adult volunteers. ... as a single dose (ranging from 45 to ...
Breaking Biology Technology:
(Date:4/15/2016)... , April 15, 2016  A new partnership ... more accurate underwriting decisions in a fraction of ... competitively priced and high-value life insurance policies to ... With Force Diagnostics, rapid testing (A1C, ... data readings (blood pressure, weight, pulse, BMI, and ...
(Date:4/14/2016)... 2016 BioCatch ™, the ... announced the appointment of Eyal Goldwerger as ... Goldwerger,s leadership appointment comes at a time of ... deployment of its platform at several of the world,s ... discerns unique cognitive and physiological factors, is a winner ...
(Date:3/31/2016)... 31, 2016   ... the "Company") LegacyXChange is excited to release ... soon to be launched online site for trading 100% ... ) will also provide potential shareholders a sense of ... to an industry that is notorious for fraud. The ...
Breaking Biology News(10 mins):