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
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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 |
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 |
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) |
- Effect on bleeding, defined as change in bleeding score
- Transfusion requirements
- Bleeding evaluation
- 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 |
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

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
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 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
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 |
Hemostatic Disorders Blood Coagulation Disorders Hemorrhage Pathologic Processes |
Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |