A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
PROLONG-9FP is a pivotal pediatric phase III study to evaluate the safety, efficacy and pharmacokinetics of recombinant fusion protein linking coagulation factor IX with recombinant albumin (rIX-FP) in previously treated children (up to age 11 years).
CSL Behring is currently enrolling patients for its Phase III pediatric trial. Learn more about the study design on www.clinicaltrials.gov.
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
Information about this Phase II/III recombinant factor study can be found at
Results of a Phase I study evaluating recombinant fusion protein linking coagulation Factor IX with albumin (rIX-FP) in patients with severe hemophilia B were publicly presented and published in BLOOD 2012 (e-print available) showing that rIX-FP achieved a 91.57 hours mean half-life, incremental recovery of 1.376 (IU/dL) / (IU/kg), and clearance of 0.75 mL/h/kg. This was an extension in half-life of 5.3 times that of the currently available recombinant FIX therapy. The trial was registered at www.clinicaltrials.gov as no. NCT01233440.
7/7/2014 10:38 PM