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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

77

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

March 31, 2013

Study Completion Date

December 31, 2016

Conditions
Hemophilia B
Interventions
BIOLOGICAL

IB1001

Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa; Study Part 2: Non-randomized, open-label evaluation of prophylaxis and on demand IB1001; Surgical Sub-study: Open-label evaluation of IB1001 during major surgery

BIOLOGICAL

nonacog alfa

Study Part 1: Randomized, double-blind, cross-over study with IB1001 and nonacog alfa

Trial Locations (23)

19104

The Children's Hospital of Philadelphia, Philadelphia

30322

Emory University School of Medicine Pediatric Hematology, Atlanta

44093

Centre Regional de Traitement de l 'Hemophilie, Nantes

45229

Hemophilia and Thrombosis Center, Cincinnati

46260

Indiana Hemophilia & Thrombosis Center, Indianapolis

52621

The National Hemophilia Center-Sheba MC, Tel Litwinsky

55455

University of Minnesota Center for Bleeding and Clotting Disorder, Minneapolis

60612

Rush University Medical Center-Pediatric Hematology Oncology, Chicago

69437

Hopital Edouard Herriot, Lyon

77030

University of Texas Health Science Center-Houston, Gulf States Hemophilia & Thrombophilia Center, Houston

89109

Hemophilia Treatment Center of Las Vegas, Las Vegas

90007

The Hemophilia Treatment Center of Orthopaedic Hospital, Los Angeles

91010

City of Hope, Duarte

411 004

Sahyadri Specialty Hospital, Deccan Gymkhana, Pune

411 011

Jehangir Clinical Development Centre, Pune

I-50134

Ospedale di Careggi, Florence

I-20122

University of Milan, Milan

02-106

MTZ Clinical Research, Warsaw

NW3 2QG

Royal Free Hospital, London

M13 9WL

Manchester Haemophilia Comprehensive Care Manchester Royal Infirmary, Manchester

S102JF

Royal Hallamshire Hospital, Sheffield

RG24 9NA

Centre for Haemostasis and Thrombosis, Basingstoke and North Hampshire Foundation Trust, Basingstoke

CF4 4XN

University Hospital of Wales Health Park, Cardiff

Sponsors
All Listed Sponsors
lead

Medexus Pharma, Inc.

INDUSTRY