This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01564563
First received: March 23, 2012
Last updated: February 23, 2017
Last verified: February 2017
March 23, 2012
February 23, 2017
June 28, 2002
October 27, 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 NCT01564563 on ClinicalTrials.gov Archive Site
  • Transfusion requirements
  • Bleeding evaluation
  • Adverse events
  • Changes in safety coagulation parameters
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
Intervention Model: Parallel Assignment
Masking: Participant, 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 27, 2003
October 27, 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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01564563
F7SCT-1485
No
Not Provided
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
February 2017

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