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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562158
First received: March 22, 2012
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.


Condition Intervention Phase
Acquired Bleeding Disorder
Bleeding During/Following Surgery
Procedure: standard therapy
Drug: activated recombinant human factor VII
Drug: placebo
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-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

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 [ 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 ]

Enrollment: 100
Study Start Date: April 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Procedure: standard therapy
Standard treatment of bleeding
Drug: placebo
Placebo
Experimental: Low dose Procedure: 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: Medium dose Procedure: standard therapy
Standard treatment of bleeding
Drug: activated recombinant human factor VII
Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
Experimental: High dose Procedure: 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 allogeneic or autologous 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: NCT01562158

Locations
Australia
Parkville, Australia, 3050
Denmark
København, Denmark, 2100
Finland
Helsinki, Finland, 00029
Germany
Regensburg, Germany, 93042
Israel
Haifa, Israel, 31096
Italy
Genova, Italy, 16132
Singapore
Singapore, Singapore, 169608
Spain
Valencia, Spain, 46026
Sweden
Stockholm, Sweden, 141 86
Switzerland
Basel, Switzerland, 4031
United Kingdom
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Liselotte Hyveled Novo Nordisk A/S
Study Director: Bettina Gaspar-Blaudschun Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01562158     History of Changes
Other Study ID Numbers: F7BMT-1360
Study First Received: March 22, 2012
Last Updated: December 10, 2012
Health Authority: Denmark: Danish Medicines Agency
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
Israel: Ministry of Health
Italy: AIFA, National Medicines Agency
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Australia: Department of Health and Ageing Therapeutic Goods Administration
Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on November 19, 2014