Brief Title
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
Official Title
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
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 hemophilia B.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Change in Frequency of Spontaneous Bleeding Events Between On-demand and Prophylaxis Treatments (Annualized)
Secondary Outcome
The Frequency of Related Adverse Events
Condition
Hemophilia B
Intervention
rIX-FP
Study Arms / Comparison Groups
Prophylaxis
Description: Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial. Subjects may participate in a surgical 'sub-study' in which rIX-FP may be administered prior to, during and after surgical intervention.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
63
Start Date
February 2012
Primary Completion Date
July 2014
Eligibility Criteria
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
Gender
Male
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Program Director, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01496274
Organization ID
CSL654_3001
Secondary IDs
2011-002415-28
Responsible Party
Sponsor
Study Sponsor
CSL Behring
Study Sponsor
Program Director, Study Director, CSL Behring
Verification Date
April 2016