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

This study has been terminated.
(Trial enrollment was prematurely terminated due to excessively slow patient recruitment)
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01564563
First received: March 23, 2012
Last updated: December 10, 2012
Last verified: December 2012
History of Changes

March 23, 2012
December 10, 2012
June 2002
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 NCT01564563 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 ]
  • Changes in safety coagulation parameters [ 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 Hematopoietic Stem Cell Transplantation
A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic 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
  • Drug: standard therapy
    Standard treatment of bleeding
  • Drug: placebo
    Placebo
  • 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)
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: standard therapy
    • Drug: placebo
  • Experimental: Low dose
    Interventions:
    • Drug: standard therapy
    • Drug: activated recombinant human factor VII
  • Experimental: High dose
    Interventions:
    • Drug: 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.
 
Terminated
11
October 2003
October 2003   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who have undergone a hematopoietic 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
United States
 
NCT01564563
F7SCT-1485
No
Not Provided
Novo Nordisk
Not Provided
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