NCT01566786View on ClinicalTrials.gov

Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage

PHASE2CompletedINTERVENTIONAL
Enrollment

48

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

October 31, 2002

Study Completion Date

October 31, 2002

Conditions
Acquired Bleeding DisorderIntracerebral Haemorrhage
Interventions
DRUG

activated recombinant human factor VII

Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult

DRUG

placebo

Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult

Trial Locations (9)

3052

Novo Nordisk Investigational Site, Parkville

17007

Novo Nordisk Investigational Site, Girona

40620

Novo Nordisk Investigational Site, Jyväskylä

60120

Novo Nordisk Investigational Site, Heidelberg

308443

Novo Nordisk Investigational Site, Singapore

Unknown

Novo Nordisk Investigational Site, Copenhagen

Novo Nordisk Investigational Site, Dawan

Novo Nordisk Investigational Site, Newcastle

00185

Novo Nordisk Investigational Site, Roma

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY