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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT01662531
First received: August 7, 2012
Last updated: September 16, 2014
Last verified: September 2014

August 7, 2012
September 16, 2014
September 2012
March 2016   (final data collection date for primary outcome measure)
  • Incremental recovery of rIX-FP [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
  • Half-life (t1/2) of a single dose of rIX-FP [ Time Frame: Approximately 10 to 14 days ] [ Designated as safety issue: No ]
  • Area under the curve (AUC) [ Time Frame: Approximately 10 to 14 days ] [ Designated as safety issue: No ]
    AUC to the last sample with quantifiable drug concentration (AUC0-t) of a single dose of rIX-FP
  • Clearance of a single dose of rIX-FP [ Time Frame: Approximately 10 to 14 days ] [ Designated as safety issue: No ]
  • Number of subjects developing Factor IX (FIX) inhibitors [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01662531 on ClinicalTrials.gov Archive Site
  • The frequency of related adverse events [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]
  • Number of subjects developing antibodies against rIX-FP [ Time Frame: Approximately 12 months ] [ Designated as safety issue: Yes ]
  • Proportion of bleeding episodes requiring one, two or more than two infusions of rIX-FP to achieve hemostasis [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]
  • Consumption of rIX-FP [ Time Frame: Approximately 12 months ] [ Designated as safety issue: No ]

    Recombinant IX-FP consumed expressed as:

    • number of infusions per month and per year
    • IU/kg per month, per year and per event
Same as current
Not Provided
Not Provided
 
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
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

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Hemophilia B
Biological: rIX-FP
Experimental: rIX-FP
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.
Intervention: Biological: rIX-FP
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
24
Not Provided
March 2016   (final data collection date for primary outcome measure)

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.
Male
up to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Canada,   Czech Republic,   France,   Germany,   Israel,   Italy,   Russian Federation,   Spain
 
NCT01662531
CSL654_3002, 2011-006032-23
Not Provided
CSL Behring
CSL Behring
Not Provided
Study Director: Program Director CSL Behring
CSL Behring
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP