Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

235

Participants

Timeline

Start Date

July 31, 2001

Primary Completion Date

December 31, 2002

Study Completion Date

December 31, 2002

Conditions
Acquired Bleeding DisorderCirrhosis
Interventions
DRUG

activated recombinant human factor VII

An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery

DRUG

activated recombinant human factor VII

An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery

DRUG

placebo

An initial placebo bolus dose followed by placebo every second hour until completion of surgery

Trial Locations (7)

100

Novo Nordisk Investigational Site, Taipei

112

Novo Nordisk Investigational Site, Taipei

10330

Novo Nordisk Investigational Site, Bangkok

10700

Novo Nordisk Investigational Site, Bangkok

100021

Novo Nordisk Investigational Site, Beijing

200438

Novo Nordisk Investigational Site, Shanghai

Unknown

Novo Nordisk Investigational Site, Beijing

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY