Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A

PHASE2CompletedINTERVENTIONAL
Enrollment

22

Participants

Timeline

Start Date

May 31, 2010

Primary Completion Date

October 31, 2011

Study Completion Date

September 30, 2012

Conditions
Hemophilia A
Interventions
BIOLOGICAL

Human-cl rhFVIII

50 IU/kg for PK dose

BIOLOGICAL

Kogenate FS

50 IU/kg for PK dose

Trial Locations (9)

20057

Georgetown University, Washington D.C.

60612

RUSH University Medical Center, Chicago

80045

University of Colorado, Denver

90007

UCLA Orthodpedic Hospital, Los Angeles

95817

University of California, Davis, Sacramento

08903

University of Medicine and Dentistry, New Brunswick

Unknown

Prof. Lissitchkov, Sofia

Medizinische Hochschule, Hanover

Vivantes Klinikum, Berlin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Octapharma

INDUSTRY

NCT00989196 - Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety and Immunogenicity of a Recombinant FVIII in Patients With Severe Hemophilia A | Biotech Hunter | Biotech Hunter