NCT00629837 - Pharmacokinetics and Safety of a Single Intravenous Infusion of BAY 79-4980 | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

September 30, 2005

Study Completion Date

March 31, 2006

Conditions

Hemophilia A

Interventions

BIOLOGICAL

Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)

Low dose of BAY 79-4980 \[13mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU).

BIOLOGICAL

Recomb. Factor VIII (Kogenate FS Liposome, BAY79-4980)

High dose of BAY 79-4980 \[22mg of liposomes/kg\] then cross over to rFVIII-FS (35 IU/kg reconstituted in 2.5 mL WFI / 1000 IU)

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to low dose of BAY 79-4980 \[13mg of liposomes/kg\]

BIOLOGICAL

Recombinant Factor VIII (Kogenate FS, BAY14-2222)

rFVIII-FS (35 IU/kg reconstituted in 2.5mL WFI /1000 IU) then cross over to high dose of BAY 79-4980 \[22mg of liposomes/kg\]

Trial Locations (2)

Davis

Orange