Clinical Trial: Study of the Pharmacokinetics and Safety of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) in Patients With Congenital Factor VII Deficiency

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Multi-center, Randomized, Open-label, Parallel-Arm, Single-dose, Pharmacokinetic Study of rVIIa-FP (CSL689) in Subjects With Congenital Factor VII Deficiency

Brief Summary: The purpose of this study is to investigate the pharmacokinetics (PK) and safety of rVIIa-FP (CSL689) in a total of 10 to 16 male or female adults with inherited coagulation factor VII (FVII) deficiency. Subjects will receive a single dose of their routine FVII replacement product (ie, either recombinant activated coagulation FVII [rFVIIa, eptacog alfa (activated)] or plasma-derived FVII [pdFVII]) as a comparator, and will then be randomly assigned to a single low dose or a single high dose of the study product CSL689 (8 subjects per CSL689 dose level). Serial blood samples for PK analysis will be taken up to 24 hours after the eptacog alfa (activated) or pdFVII injection, and up to 48 hours after the CSL689 injection. Subject safety will be routinely monitored throughout the study.

Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome:

  • Terminal half-life of plasma FVIIa activity [ Time Frame: Up to 48 hours after CSL689 injection ]
  • Maximum observed plasma FVIIa activity [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
  • Area under the curve (AUC0-t) [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
    Area under plasma FVIIa activity versus time curve from time 0 to last sample with quantifiable activity


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total clearance [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
    Total clearance of plasma FVIIa activity
  • Volume of distribution of the terminal phase [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
  • AUC(0-inf) [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
    Area under plasma FVIIa activity versus time curve from time 0 extrapolated to infinity
  • Incremental recovery [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
    Incremental recovery of plasma FVIIa activity
  • Time of occurrence of maximum observed plasma FVIIa activity [ Time Frame: Before injection and at up to 9 time points until 48 hours after injection ]
  • Number of subjects with antibodies against Chinese hamster ovary protein and FVII [ Time Frame: Up to 30 days after CSL689 injection ]
  • Number of subjects with inhibitors against FVII [ Time Frame: Up to 30 days after CSL689 injection ]


Original Secondary Outcome: Same as current

Information By: CSL Behring

Dates:
Date Received: June 10, 2015
Date Started: July 2015
Date Completion:
Last Updated: April 25, 2017
Last Verified: November 2016