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

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ClinicalTrials.gov Identifier: NCT01564563
Recruitment Status : Terminated (Trial enrollment was prematurely terminated due to excessively slow patient recruitment)
First Posted : March 28, 2012
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acquired Bleeding Disorder Bleeding During/Following Surgery Drug: standard therapy Drug: placebo Drug: activated recombinant human factor VII Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : June 28, 2002
Actual Primary Completion Date : October 27, 2003
Actual Study Completion Date : October 27, 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Effect on bleeding, defined as change in bleeding score

Secondary Outcome Measures :
  1. Transfusion requirements
  2. Bleeding evaluation
  3. Adverse events
  4. Changes in safety coagulation parameters


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564563


Locations
United States, Arkansas
Novo Nordisk Investigational Site
Little Rock, Arkansas, United States, 72205
United States, California
Novo Nordisk Investigational Site
Duarte, California, United States, 91010
United States, Maryland
Novo Nordisk Investigational Site
Baltimore, Maryland, United States, 21231-1000
United States, Missouri
Novo Nordisk Investigational Site
St. Louis, Missouri, United States, 63110
United States, New York
Novo Nordisk Investigational Site
New York, New York, United States, 10021
United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7035
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01564563     History of Changes
Other Study ID Numbers: F7SCT-1485
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders