Status:
COMPLETED
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
Lead Sponsor:
CSL Behring
Conditions:
Hemophilia B
Eligibility:
MALE
12-65 years
Phase:
PHASE2
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01496274
Start Date
February 1 2012
Last Update
May 9 2016
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Rush University Medical Center
Chicago, Illinois, United States, 60612
2
Indiana Hemophilia and Thrombosis Center, Inc.
Indianapolis, Indiana, United States, 46260
3
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
4
BloodCenter of Wisconsin
Milwaukee, Wisconsin, United States, 53201