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

January 10, 2017 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Herston, Australia, 4029
        • Novo Nordisk Investigational Site
      • Parkville, Australia, 3050
        • Novo Nordisk Investigational Site
      • Westmead, Australia, 2145
        • Novo Nordisk Investigational Site
  • Austria
      • Vienna, Austria, A -1090
        • Novo Nordisk Investigational Site
  • Denmark
      • København, Denmark, 2100
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00029
        • Novo Nordisk Investigational Site
  • France
      • Besancon, France, 25030
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Tours, France, 37044
        • Novo Nordisk Investigational Site
  • Germany
      • Dresden, Germany, 01307
        • Novo Nordisk Investigational Site
      • Hamburg, Germany, 20246
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30625
        • Novo Nordisk Investigational Site
      • Idar-Oberstein, Germany, 55743
        • Novo Nordisk Investigational Site
      • Köln, Germany, 50924
        • Novo Nordisk Investigational Site
      • München, Germany, 81377
        • Novo Nordisk Investigational Site
      • Regensburg, Germany, 93042
        • Novo Nordisk Investigational Site
      • Tübingen, Germany, 72076
        • Novo Nordisk Investigational Site
      • Wiesbaden, Germany, 65191
        • Novo Nordisk Investigational Site
  • Israel
      • Haifa, Israel, 31096
        • Novo Nordisk Investigational Site
      • Jerusalem, Israel, 91120
        • Novo Nordisk Investigational Site
  • Italy
      • Firenze, Italy, 50134
        • Novo Nordisk Investigational Site
      • Genova, Italy, 16132
        • Novo Nordisk Investigational Site
      • Pesaro, Italy, 61100
        • Novo Nordisk Investigational Site
      • Rome, Italy, 00144
        • Novo Nordisk Investigational Site
      • Udine, Italy, 33100
        • Novo Nordisk Investigational Site
  • Poland
      • Gdansk, Poland, 80-952
        • Novo Nordisk Investigational Site
      • Katowice, Poland, 40-029
        • Novo Nordisk Investigational Site
      • Poznan, Poland, 60-569
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-097
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 00-909
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 50-345
        • Novo Nordisk Investigational Site
      • Wroclaw, Poland, 53-439
        • Novo Nordisk Investigational Site
  • Singapore
      • Singapore, Singapore, 169608
        • Novo Nordisk Investigational Site
  • Spain
      • Barcelona, Spain, 08036
        • Novo Nordisk Investigational Site
      • Santander, Spain, 39008
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
      • Uppsala, Sweden, 751 85
        • Novo Nordisk Investigational Site
  • Switzerland
      • Basel, Switzerland, 4031
        • Novo Nordisk Investigational Site
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • Thailand
      • Bangkok, Thailand
        • Novo Nordisk Investigational Site
      • Bangkok, Thailand, 10330
        • Novo Nordisk Investigational Site
  • United Kingdom
      • London, United Kingdom, W12 OHS
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M20 4BX
        • Novo Nordisk Investigational Site
  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7035
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
Placebo
Procedure: standard therapy
Standard treatment of bleeding
Experimental: Low dose
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)
Procedure: standard therapy
Standard treatment of bleeding
Drug: activated recombinant human factor VII
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
Experimental: High dose
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)
Procedure: standard therapy
Standard treatment of bleeding
Drug: activated recombinant human factor VII
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
Experimental: Medium dose
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)
Procedure: standard therapy
Standard treatment of bleeding
Drug: activated recombinant human factor VII
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effect on bleeding, defined as change in bleeding score

Secondary Outcome Measures

Outcome Measure
Adverse events
Transfusion requirements
Bleeding evaluation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

October 1, 2003

Study Completion (Actual)

October 1, 2003

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 22, 2012

First Posted (Estimate)

March 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7BMT-1360

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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