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 |
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Recruitment Status :
Completed
First Posted : March 23, 2012
Last Update Posted : January 11, 2017
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Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
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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 |
| 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) |
Primary Outcome Measures :
- Effect on bleeding, defined as change in bleeding score
Secondary Outcome Measures :
- Transfusion requirements
- Bleeding evaluation
- Adverse events
Information from the National Library of Medicine
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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
| 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
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Publications of Results:
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 |
Additional relevant MeSH terms:
|
Hemostatic Disorders Blood Coagulation Disorders Hemorrhage Pathologic Processes |
Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |