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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 (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01564563
First received: March 23, 2012
Last updated: February 23, 2017
Last verified: February 2017
  Purpose
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 Intervention Phase
Acquired Bleeding Disorder
Bleeding During/Following Surgery
Drug: standard therapy
Drug: placebo
Drug: activated recombinant human factor VII
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • Transfusion requirements
  • Bleeding evaluation
  • Adverse events
  • Changes in safety coagulation parameters

Enrollment: 11
Actual Study Start Date: June 28, 2002
Study Completion Date: October 27, 2003
Primary Completion Date: October 27, 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01564563     History of Changes
Other Study ID Numbers: F7SCT-1485
Study First Received: March 23, 2012
Last Updated: February 23, 2017

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

ClinicalTrials.gov processed this record on May 23, 2017