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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562158
First Posted: March 23, 2012
Last Update Posted: January 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
March 22, 2012
March 23, 2012
January 11, 2017
April 2001
October 2003   (Final data collection date for primary outcome measure)
Effect on bleeding, defined as change in bleeding score
Same as current
Complete list of historical versions of study NCT01562158 on ClinicalTrials.gov Archive Site
  • Transfusion requirements
  • Bleeding evaluation
  • Adverse events
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Acquired Bleeding Disorder
  • Bleeding During/Following Surgery
  • 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
  • Placebo Comparator: Placebo
    Interventions:
    • Procedure: standard therapy
    • Drug: placebo
  • Experimental: Low dose
    Interventions:
    • Procedure: standard therapy
    • Drug: activated recombinant human factor VII
  • Experimental: Medium dose
    Interventions:
    • Procedure: standard therapy
    • Drug: activated recombinant human factor VII
  • Experimental: High dose
    Interventions:
    • Procedure: standard therapy
    • Drug: activated recombinant human factor VII
Pihusch M, Bacigalupo A, Szer J, von Depka Prondzinski M, Gaspar-Blaudschun B, Hyveled L, Brenner B; F7BMT-1360 Trial Investigators. Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
October 2003
October 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Denmark,   Finland,   France,   Germany,   Israel,   Italy,   Poland,   Singapore,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom,   United States
 
 
NCT01562158
F7BMT-1360
No
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP