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



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 65
Updated:4/21/2016
Start Date:February 2012

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A Phase II/III Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control
and prevention of bleeding episodes in subjects who have previously received factor
replacement therapy for hemophilia B.


Inclusion Criteria:

- Male subjects, 12 to 65 years old

- Severe hemophilia B (FIX activity of ≤ 2%)

- Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for >
150 exposure days (EDs)

- No history of FIX inhibitor formation, no detectable inhibitors at Screening and no
family history of inhibitors against FIX

- Written informed consent for study participation

- On-demand subjects only, who have experienced a minimum average of 2 non-trauma
induced bleeding episodes requiring treatment with a FIX product during the previous
6 or 3 months

Exclusion Criteria:

- Known hypersensitivity to any FIX product or hamster protein

- Known congenital or acquired coagulation disorder other than congenital FIX
deficiency

- HIV positive subjects with a CD4 count < 200/mm3

- Low platelet count, kidney or liver dysfunction

- Recent life-threatening bleeding episode
We found this trial at
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
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Indianapolis, Indiana 46260
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Milwaukee, Wisconsin 53201
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