Study of Recombinant Factor IX Product, IB1001, in Previously Treated Subjects With Hemophilia B

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

March 31, 2014

Primary Completion Date

October 31, 2015

Study Completion Date

November 30, 2015

Conditions
Hemophilia B
Interventions
BIOLOGICAL

IB1001

"Prophylaxis (during Treatment and Continuation phases): 40 - 75 IU/kg twice weekly.~The starting dose for prophylaxis may be based on previous recombinant factor IX product use. The recommended starting prophylaxis dose is 40 - 60 IU/kg twice weekly, however, the investigator may prescribe up to 75 IU/kg twice weekly at their discretion (after clinically assessing the subject) and discretion of the subject.~The dose or the frequency of IB1001 prophylaxis may be adjusted at the discretion of the investigator."

Trial Locations (2)

Unknown

Chicago

Manchester

Sponsors
All Listed Sponsors
lead

Cangene Corporation

INDUSTRY