Share

CSL Behring has initiated a global phase II/III, multi-centre study, designed to investigate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP). The prospective open-label study will enrol adolescents and adults aged between 12 and 65 years who have haemophilia B.

The phase II/III study includes a screening period, a pharmacokinetic evaluation period, followed by a 12-month safety and efficacy evaluation period with rIX-FP, and consists of a surgical prophylaxis sub-trial.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

CSL Behring, in partnership with parent company CSL Limited is developing rIX-FP for the prophylaxis and treatment of bleeding episodes in patients with congenital factor IX deficiency as part of the Prolong-9FP clinical study programme.

CSL Behring Global Clinical R&D senior vice-president Russell Basser said that the therapy using recombinant fusion protein linking coagulation factor IX with recombinant albumin can mean fewer injections for patients, and may enable or enhance prophylactic treatment, improving quality of life for patients.

"The unmet medical need is great for a factor IX product with an extended half-life for use in treating people with haemophilia B, a life-long, debilitating clotting disorder," said Basser.

See Also:

Principal investigator of the study Elena Santagostino said the recombinant factor IX product with a longer half-life will have the potential to prevent bleeding in people who have haemophilia B.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

”The product in development today aims to reduce the number of infusions a patient with haemophilia must undergo," said Santagostino. "As treating physicians and clinical researchers, we are proud to be a part of this effort and look forward with great anticipation to the results of our research."

Caption: Deficiency in coagulation factor VIII is the most common cause of haemophilia.