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:
Novo Nordisk A/S
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
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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:
MedlinePlus related topics:
Bleeding
Drug Information available for:
Eptacog alfa (activated)
U.S. FDA Resources
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 (Child, Adult, Senior) |
| 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
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:
| 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:
|
Hemorrhage Blood Coagulation Disorders Hemostatic Disorders Pathologic Processes |
Hematologic Diseases Vascular Diseases Cardiovascular Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on September 27, 2016