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

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

July 31, 2015

Primary Completion Date

July 31, 2016

Study Completion Date

October 31, 2016

Conditions
Congenital Coagulation Factor VII Deficiency
Interventions
BIOLOGICAL

Eptacog alfa (activated) or pdFVII

"Comparator Drug 1: Recombinant activated FVII (rFVIIa). Subjects with eptacog alfa (activated) as their routine FVII replacement therapy will receive a single dose of eptacog alfa (activated) in the study.~Comparator Drug 2: Plasma-derived FVII (pdFVII). Subjects with pdFVII as their routine FVII replacement therapy will receive a single injection of pdFVII in the study."

BIOLOGICAL

CSL689

Experimental Drug: Recombinant fusion protein, linking activated FVII with albumin (rVIIa-FP). Subjects will receive a single dose of CSL689 at either a low dose (Arm 1) or a high dose (Arm 2)

Trial Locations (2)

6500

Site Reference 5280023, Njmegen

0372

Site Reference # 5780001, Oslo

Sponsors

Lead Sponsor

All Listed Sponsors
lead

CSL Behring

INDUSTRY