Our Clinical Trials

Hemophilia A

We have concluded late-stage clinical trials (Phase III) that evaluated long-lasting recombinant factor VIII (rFVIIIFc). We anticipate submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013.

rFVIIIFc Phase III Study

  • rFVIIIFc was evaluated in clinical trials for people with hemophilia A
  • This Phase III study investigated the safety, pharmacokinetics (the determination of the concentration of a drug in the blood over time), and efficacy (activity and length of effect) of rFVIIIFc in the prevention and treatment of bleeding in previously treated people with hemophilia A
Click here to learn about the different phases of clinical trials

rFVIIIFc Pediatric Study

  • This study is investigating the safety, pharmacokinetics (the determination of the concentration of a drug in the blood over time), and efficacy (activity and length of effect) of rFVIIIFc in the prevention and treatment of bleeding episodes in previously treated children with hemophilia A
rFVIIIFc Extension Study
  • This study is investigating the long-term safety and efficacy (activity and length of effect) of rFVIIIFc in previously treated subjects with hemophilia A
  • This study is open only to subjects who have completed other Biogen Idec Hemophilia studies using rFVIIIFc, and will allow eligible subjects to continue treatment with rFVIIIFc if they wish
For information about the A-LONG, Kids A-LONG, or A-SPIRE clinical trials, contact us at 866-MEDINFO or visit www.clinicaltrials.gov and search for "rFVIIIFc."

 

Hemophilia B

We have concluded late-stage clinical trials (Phase III) that evaluated long-lasting recombinant factor IX (rFIXFc). We anticipate submitting a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first half of 2013.

rFIXFc Phase III Study

  • rFIXFc was evaluated in clinical trials for people with hemophilia B
  • This Phase III study investigated the safety, pharmacokinetics (the determination of the concentration of drug in the blood over time), and efficacy (activity and length of effect) of rFIXFc in the prevention and treatment of bleeding in previously treated people with hemophilia B
Click here to learn about the different phases of clinical trials

rFIXFc Pediatric Study

  • This study is investigating the safety, pharmacokinetics (the determination of the concentration of a drug in the blood over time), and efficacy (activity and length of effect) of rFIXFc in the prevention and treatment of bleeding episodes in previously treated children with hemophilia B
rFIXFc Extension Study
  • This study is investigating the long-term safety and efficacy (activity and length of effect) of rFIXFc in the prevention and treatment of bleeding episodes in previously treated people with hemophilia B
  • This study is only open to people who have completed other Biogen Idec Hemophilia studies using rFIXFc, and will allow eligible subjects to continue treatment with rFIXFc if they wish
For information about the B-LONG, Kids B-LONG, or B-YOND clinical trials, contact us at 866-MEDINFO or visit www.clinicaltrials.gov and search for "rFIXFc."

 
         
    

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