Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

PHASE2CompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

April 30, 2001

Primary Completion Date

October 31, 2003

Study Completion Date

October 31, 2003

Conditions
Acquired Bleeding DisorderBleeding During/Following Surgery
Interventions
PROCEDURE

standard therapy

Standard treatment of bleeding

DRUG

activated recombinant human factor VII

Two days repeated treatment regimen - low dose administered i.v. (into the vein)

DRUG

activated recombinant human factor VII

Two days repeated treatment regimen - medium dose administered i.v. (into the vein)

DRUG

activated recombinant human factor VII

Two days repeated treatment regimen - high dose administered i.v. (into the vein)

DRUG

placebo

Placebo

Trial Locations (46)

2100

Novo Nordisk Investigational Site, Copenhagen

2145

Novo Nordisk Investigational Site, Westmead

3050

Novo Nordisk Investigational Site, Parkville

4029

Novo Nordisk Investigational Site, Herston

4031

Novo Nordisk Investigational Site, Basel

8091

Novo Nordisk Investigational Site, Zurich

10330

Novo Nordisk Investigational Site, Bangkok

16132

Novo Nordisk Investigational Site, Genova

20246

Novo Nordisk Investigational Site, Hamburg

25030

Novo Nordisk Investigational Site, Besançon

30625

Novo Nordisk Investigational Site, Hanover

31096

Novo Nordisk Investigational Site, Haifa

33100

Novo Nordisk Investigational Site, Udine

37044

Novo Nordisk Investigational Site, Tours

39008

Novo Nordisk Investigational Site, Santander

46026

Novo Nordisk Investigational Site, Valencia

50134

Novo Nordisk Investigational Site, Florence

50924

Novo Nordisk Investigational Site, Cologne

55743

Novo Nordisk Investigational Site, Idar-Oberstein

59037

Novo Nordisk Investigational Site, Lille

61100

Novo Nordisk Investigational Site, Pesaro

65191

Novo Nordisk Investigational Site, Wiesbaden

72076

Novo Nordisk Investigational Site, Tübingen

81377

Novo Nordisk Investigational Site, München

91120

Novo Nordisk Investigational Site, Jerusalem

93042

Novo Nordisk Investigational Site, Regensburg

169608

Novo Nordisk Investigational Site, Singapore

27599-7035

Novo Nordisk Investigational Site, Chapel Hill

A -1090

Novo Nordisk Investigational Site, Vienna

00029

Novo Nordisk Investigational Site, Helsinki

01307

Novo Nordisk Investigational Site, Dresden

00144

Novo Nordisk Investigational Site, Rome

80-952

Novo Nordisk Investigational Site, Gdansk

40-029

Novo Nordisk Investigational Site, Katowice

60-569

Novo Nordisk Investigational Site, Poznan

00-909

Novo Nordisk Investigational Site, Warsaw

02-097

Novo Nordisk Investigational Site, Warsaw

50-345

Novo Nordisk Investigational Site, Wroclaw

53-439

Novo Nordisk Investigational Site, Wroclaw

08036

Novo Nordisk Investigational Site, Barcelona

413 45

Novo Nordisk Investigational Site, Gothenburg

141 86

Novo Nordisk Investigational Site, Stockholm

751 85

Novo Nordisk Investigational Site, Uppsala

Unknown

Novo Nordisk Investigational Site, Bangkok

W12 OHS

Novo Nordisk Investigational Site, London

M20 4BX

Novo Nordisk Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY