Brief Title
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
Official Title
A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B
Brief Summary
This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product
Secondary Outcome
Number of Subjects With Treatment-related Adverse Events
Condition
Hemophilia B
Intervention
rIX-FP
Study Arms / Comparison Groups
rIX-FP
Description: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.
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
27
Start Date
January 2013
Primary Completion Date
October 2014
Eligibility Criteria
Inclusion Criteria: - Male subjects, younger than 12 years old. - Severe hemophilia B (Factor IX [FIX] activity of ≤ 2%). - Body weight ≥ 10 kg. - Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for > 150 exposure days (EDs) (6 to < 12 years), and > 50 EDs (< 6 years). - 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. Exclusion Criteria: - Known hypersensitivity to any FIX product or hamster protein. - Known congenital or acquired coagulation disorder other than congenital FIX deficiency. - Kidney or liver disease. - Recent life-threatening bleeding episode.
Gender
Male
Ages
N/A - 11 Years
Accepts Healthy Volunteers
No
Contacts
Program Director, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT01662531
Organization ID
CSL654_3002
Secondary IDs
2011-006032-23
Responsible Party
Sponsor
Study Sponsor
CSL Behring
Study Sponsor
Program Director, Study Director, CSL Behring
Verification Date
April 2016