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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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Effect on bleeding, defined as change in bleeding score [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 11
Study Start Date: June 2002
Study Completion Date: October 2003
Primary Completion Date: October 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564563

Locations
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21231-1000
United States, Missouri
Novo Nordisk Clinical Trial Call Center
St. Louis, Missouri, United States, 63110
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Chapel Hill, North Carolina, United States, 27599-7035
United States, Texas
Novo Nordisk Clinical Trial Call Center
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Bettina Gaspar-Blaudschun Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT01564563     History of Changes
Other Study ID Numbers: F7SCT-1485
Study First Received: March 23, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2013