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

PHASE2TerminatedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

June 28, 2002

Primary Completion Date

October 27, 2003

Study Completion Date

October 27, 2003

Conditions
Acquired Bleeding DisorderBleeding During/Following Surgery
Interventions
DRUG

standard therapy

Standard treatment of bleeding

DRUG

placebo

Placebo

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 - high dose administered i.v. (into the vein)

Trial Locations (7)

10021

Novo Nordisk Investigational Site, New York

63110

Novo Nordisk Investigational Site, St Louis

72205

Novo Nordisk Investigational Site, Little Rock

91010

Novo Nordisk Investigational Site, Duarte

21231-1000

Novo Nordisk Investigational Site, Baltimore

27599-7035

Novo Nordisk Investigational Site, Chapel Hill

77030-4009

Novo Nordisk Investigational Site, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01564563 - Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation | Biotech Hunter | Biotech Hunter