NCT02484638 - Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

July 23, 2015

Primary Completion Date

March 28, 2018

Study Completion Date

March 28, 2018

Conditions

Hemophilia A With InhibitorsHemophilia B With Inhibitors

Interventions

DRUG

CSL689

Recombinant fusion protein, linking activated coagulation factor VII with albumin. Two dose levels (low dose, high dose) will be studied in Parts 1, 2, and 3.

DRUG

Eptacog alfa (activated)

Recombinant activated coagulation factor VII. Two dose levels (low dose, high dose) will be studied in Part 1.

Trial Locations (10)

2193

Site Reference # 7100001, Johannesburg

10400

Site Reference # 7640006, Bangkok

20122

Site Reference # 3800023, Milan

28046

Site Reference # 7240007, Madrid

40002

Site Reference # 7640004, Khon Kaen

50400

Site Reference # 4580001, Kuala Lumpur

79044

Site Reference # 8040005, Lviv

650061

Site Reference # 6430026, Kemerovo

0179

Site Reference # 2680001, Tbilisi

NW3 2 QG

Site Reference # 8260008, London