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.
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.
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.
''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.