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

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ClinicalTrials.gov Identifier: NCT01562158
Recruitment Status : Completed
First Posted : March 23, 2012
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : April 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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)




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


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01562158


Locations
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United States, North Carolina
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States, 27599-7035
Australia
Novo Nordisk Investigational Site
Herston, Australia, 4029
Novo Nordisk Investigational Site
Parkville, Australia, 3050
Novo Nordisk Investigational Site
Westmead, Australia, 2145
Austria
Novo Nordisk Investigational Site
Vienna, Austria, A -1090
Denmark
Novo Nordisk Investigational Site
København, Denmark, 2100
Finland
Novo Nordisk Investigational Site
Helsinki, Finland, 00029
France
Novo Nordisk Investigational Site
Besancon, France, 25030
Novo Nordisk Investigational Site
Lille, France, 59037
Novo Nordisk Investigational Site
Tours, France, 37044
Germany
Novo Nordisk Investigational Site
Dresden, Germany, 01307
Novo Nordisk Investigational Site
Hamburg, Germany, 20246
Novo Nordisk Investigational Site
Hannover, Germany, 30625
Novo Nordisk Investigational Site
Idar-Oberstein, Germany, 55743
Novo Nordisk Investigational Site
Köln, Germany, 50924
Novo Nordisk Investigational Site
München, Germany, 81377
Novo Nordisk Investigational Site
Regensburg, Germany, 93042
Novo Nordisk Investigational Site
Tübingen, Germany, 72076
Novo Nordisk Investigational Site
Wiesbaden, Germany, 65191
Israel
Novo Nordisk Investigational Site
Haifa, Israel, 31096
Novo Nordisk Investigational Site
Jerusalem, Israel, 91120
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Genova, Italy, 16132
Novo Nordisk Investigational Site
Pesaro, Italy, 61100
Novo Nordisk Investigational Site
Rome, Italy, 00144
Novo Nordisk Investigational Site
Udine, Italy, 33100
Poland
Novo Nordisk Investigational Site
Gdansk, Poland, 80-952
Novo Nordisk Investigational Site
Katowice, Poland, 40-029
Novo Nordisk Investigational Site
Poznan, Poland, 60-569
Novo Nordisk Investigational Site
Warszawa, Poland, 00-909
Novo Nordisk Investigational Site
Warszawa, Poland, 02-097
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-345
Novo Nordisk Investigational Site
Wroclaw, Poland, 53-439
Singapore
Novo Nordisk Investigational Site
Singapore, Singapore, 169608
Spain
Novo Nordisk Investigational Site
Barcelona, Spain, 08036
Novo Nordisk Investigational Site
Santander, Spain, 39008
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 413 45
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
Novo Nordisk Investigational Site
Uppsala, Sweden, 751 85
Switzerland
Novo Nordisk Investigational Site
Basel, Switzerland, 4031
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, W12 OHS
Novo Nordisk Investigational Site
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562158    
Other Study ID Numbers: F7BMT-1360
First Posted: March 23, 2012    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders