Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII for Preventing Early Hematoma Growth in Acute Intracerebral Haemorrhage

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

November 30, 2001

Primary Completion Date

March 31, 2003

Study Completion Date

March 31, 2003

Conditions
Acquired Bleeding DisorderIntracerebral Haemorrhage
Interventions
DRUG

activated recombinant human factor VII

Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult

DRUG

placebo

Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult

Trial Locations (1)

10032

Novo Nordisk Investigational Site, New York

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY