Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B

PHASE3CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

November 13, 2014

Primary Completion Date

August 20, 2019

Study Completion Date

August 20, 2019

Conditions
Hemophilia B
Interventions
BIOLOGICAL

rFIXFc

Adjustments to the dose and interval of rFIXFc was made in this study based on investigator discretion using available pharmacokinetic (PK) data, subsequent FIX trough and peak levels, level of physical activity, and bleeding pattern, in accordance with local standards of care for a prophylactic regimen. There was an option to start study dosing as episodic treatment (on-demand).

Trial Locations (27)

1023

Research Site, Auckland

2145

Research Site, Westmead

8200

Research Site, Aarhus

15213

Research Site, Pittsburgh

20010

Research Site, Washington D.C.

20122

Research Site, Milan

30322

Research Site, Atlanta

40202

Research Site, Louisville

43126

Research Site, Parma

43205

Research Site, Columbus

46260

Research Site, Indianapolis

48823

Research Site, East Lansing

49684

Research Site, Traverse City

59037

Hopital Cardiologique - CHU Lille, Lille

69437

Research Site, Lyon

70112

Research Site, New Orleans

80122

Research Site, Napoli

95817

Research Site, Sacramento

97239

Research Site, Portland

D12 N512

Research Site, Dublin

00165

Research Site, Roma

3584 CX

Research Site, Utrecht

02-091

Research Site, Warsaw

205 02

Research Site, Malmo

CB2 0QQ

Research Site, Cambridge

E1 1BB

Research Site, Whitechapel

WC1N3JH

Research Site, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Swedish Orphan Biovitrum

INDUSTRY

lead

Bioverativ, a Sanofi company

INDUSTRY