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OpenTrials
Completed

NCT Number: NCT01562158

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

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.

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Key information

Conditions

Acquired Bleeding Disorder Bleeding During/Following Surgery

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Herston, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have undergone allogeneic or autologous stem cell transplantation

Exclusion criteria

  • Known or suspected allergy to trial product
  • Participation in other trials with unapproved drugs or trials with equal or similar objective

Treatment and study plan

standard therapy

Procedure

Standard treatment of bleeding

activated recombinant human factor VII

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. Effect on bleeding, defined as change in bleeding score

Secondary outcomes

  1. Transfusion requirements

  2. Bleeding evaluation

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Mar 23, 2012
Registry last updated
Jan 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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