NCT01153997 - Safety of Recombinant Factor XIII (rFXIII) in Healthy Japanese Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2010

Primary Completion Date

August 31, 2010

Study Completion Date

August 31, 2010

Conditions

Acquired Bleeding DisorderCardiac Surgery Requiring Cardiopulmonary BypassHealthy

Interventions

DRUG

catridecacog

Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

DRUG

placebo

Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

DRUG

catridecacog

Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

DRUG

placebo

Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.

Trial Locations (1)

Fukuoka