NCT01599819 - BAX 855 Dose-Escalation Safety Study | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

July 27, 2012

Study Completion Date

July 27, 2012

Conditions

Hemophilia A

Interventions

BIOLOGICAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)

BIOLOGICAL

PEGylated Recombinant Factor VIII

1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)

Trial Locations (8)

"Specialized Hospital for Active Treatment Joan Pavel", Sofia

Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults, Berlin

UKGM Uniklinikum Giessen & Marburg, Giessen

Harrison Clinical Research Deutschland, Munich

Nara Medical University Hospital, Nara

Tokyo Medical University Hospital, Tokyo

Quintiles Drug Research Unit at Guy´s Hospital, London

Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary, Manchester