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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:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01562158
First received: March 22, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes

March 22, 2012
December 10, 2012
April 2001
October 2003   (final data collection date for primary outcome measure)
Effect on bleeding, defined as change in bleeding score [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01562158 on ClinicalTrials.gov Archive Site
  • Transfusion requirements [ Designated as safety issue: No ]
  • Bleeding evaluation [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Not Provided

*   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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Denmark,   Finland,   Germany,   Israel,   Italy,   Singapore,   Spain,   Sweden,   Switzerland,   United Kingdom
 
NCT01562158
F7BMT-1360
No
Not Provided
Novo Nordisk
Not Provided
Study Director: Liselotte Hyveled Novo Nordisk
Study Director: Bettina Gaspar-Blaudschun Novo Nordisk
Novo Nordisk
December 2012

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