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All About Bleeding

PROLONG-9FP Clinical Studies

IDELVION® for Hemophilia B Now Available in US

21 March 2016 - Long-acting recombinant Factor IX

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European Commission Approves IDELVION®

11 May 2016 - CSL Behring’s Novel Hemophilia B Treatment with Up to 14-day Dosing Intervals

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Novel Recombinant Hemophilia Treatments

CSL Behring’s recombinant factor development pipeline is built on its strength in protein research and development and scientific expertise in bleeding disorders

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Population Pharmacokinetic Model for rIX-FP Presented at ISTH

Recombinant albumin fusion platform forms basis of innovation.

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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

PROLONG-9FP (CSL654_3002) 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).

Information about the study design is available on www.clinicaltrials.gov.

A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

Study information is available on www.clinicaltrials.gov. (PROLONG-9FP CSL654_3003)

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 www.clinicaltrials.gov. (PROLONG CSL654_3001)

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.





Last Updated: 9/12/2014 1:43 PM
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