CSL Behring aims to identify, develop and commercialize important new biotherapeutic products that save lives by preventing or treating serious medical conditions, including rare bleeding disorders. We are committed to significantly investing in our future research and development (R&D) portfolio and capabilities in the area of coagulation, including plasma replacement treatments and therapeutic proteins using recombinant technology. An overview of planned, current and finalized clinical trials may be found on clinicaltrials.gov. We also encourage independent research within the area of bleeding disorders by providing study grants both globally and locally.
Substitution therapies
Research advances in our recombinant coagulation program have resulted in pre-clinical proof of principle data showing extended half-life for recombinant factor VIIa and factor IX albumin fusion proteins (rVIIa FP and rIX FP)
Studies supported by CSL Behring
The von Willebrand Disease Prophylaxis Network
The von Willebrand Disease Prophylaxis Network (vWD PN) is an international study group formed with the goal of studying the role of prophylaxis in clinically severe von Willebrand disease that is non-responsive to other treatment(s). The VWD International Prophylaxis (VIP) study is an initiative of the vWD PN. The primary objectives of the VIP study are to examine the effect of prophylaxis on bleeding frequency, and to establish optimal treatment regimens for joint bleeding, GI bleeding, epistaxis, and menorrhagia.
Information is available on the VWD/PN site and at Clinical Trials.gov.
International Immune Tolerance Study
This study was initiated in July 2002 as a prospective randomized multi-center trial to evaluate low- vs. high-dose immune tolerance in good-risk patients with severe hemophilia A.
The study was closed by the DSMB in November 2009 due to increased risk of bleeding in the low dose group. Data is currently being evaluated. The study information is available at Clinical Trials.gov.
Rescue Immunotolerance Study in Induction of Immune Tolerance (RESIST)
RESIST’s aim is to evaluate if Factor VIII/von Willebrand Factor (vWF) concentrates can successfully induce immune tolerance in high risk patients. This two-part study complements the International Immune Tolerance Study, an observational study in patients who had already experienced a failure with a VWF-free FVIII concentrate (called RESIST experienced), as well as a randomized, controlled study in patients who have never tried an ITI treatment before and are at high risk to fail (called RESIST naive).
Study information is available on ClinicalTrials.gov for RESIST (experienced). Study information is available on ClinicalTrials.gov for RESIST (naïve).
Last Updated:
5/28/2010 7:25 PM