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

NCT01562158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-01-11

No results posted yet for this study

Summary

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.

Conditions

  • Acquired Bleeding Disorder
  • Bleeding 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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-04-30
Primary Completion
2003-10-31
Completion
2003-10-31

Countries

  • United States
  • Australia
  • Austria
  • Denmark
  • Finland
  • France
  • Germany
  • Israel
  • Italy
  • Poland
  • Singapore
  • Spain
  • Sweden
  • Switzerland
  • Thailand
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562158 on ClinicalTrials.gov