Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

208

Participants

Timeline

Start Date

August 31, 2001

Primary Completion Date

August 31, 2003

Study Completion Date

August 31, 2003

Conditions
Acquired Bleeding DisorderBleeding During/Following Surgery
Interventions
DRUG

activated recombinant human factor VII

120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure

DRUG

activated recombinant human factor VII

60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure

DRUG

placebo

Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure

Trial Locations (18)

2050

Novo Nordisk Investigational Site, Camperdown

3084

Novo Nordisk Investigational Site, Heidelberg

13353

Novo Nordisk Investigational Site, Berlin

45122

Novo Nordisk Investigational Site, Essen

46026

Novo Nordisk Investigational Site, Valencia

48903

Novo Nordisk Investigational Site, Barakaldo

V5Z 1M9

Novo Nordisk Investigational Site, Vancouver

N6A 5A5

Novo Nordisk Investigational Site, London

H3H1A1

Novo Nordisk Investigational Site, Québec

M5G-2C4

Novo Nordisk Investigational Site, Toronto

92 188

Novo Nordisk Investigational Site, Clichy

08036

Novo Nordisk Investigational Site, Barcelona

413 45

Novo Nordisk Investigational Site, Gothenburg

141 86

Novo Nordisk Investigational Site, Stockholm

B15 2TH

Novo Nordisk Investigational Site, Birmingham

Unknown

Novo Nordisk Investigational Site, Edinburgh

LS9 7TS

Novo Nordisk Investigational Site, Leeds

SE5 9RS

Novo Nordisk Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY