Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

December 31, 2009

Study Completion Date

December 31, 2009

Conditions
Hemophilia AHemophilia B
Interventions
DRUG

BAY Factor VII (BAY86-6150)

BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

DRUG

BAY Factor VII (BAY86-6150)

BAY Factor VII (BAY86-6150), 20 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

DRUG

BAY Factor VII (BAY86-6150)

BAY Factor VII (BAY86-6150), 50 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

DRUG

BAY Factor VII (BAY86-6150)

BAY Factor VII (BAY86-6150), 90 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

DRUG

Placebo

Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.

Trial Locations (4)

2193

Johannesburg

9300

Bloemfontein

02-776

Warsaw

W12 0HS

London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bayer

INDUSTRY

NCT01921855 - Study of FVIIa Variant BAY86-6150 (B0189) in Subjects With Moderate or Severe Hemophilia Types A or B With or Without Inhibitors | Biotech Hunter | Biotech Hunter