Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT01562158
Status:
COMPLETED
Last Update Posted:
2017-01-11
First Post:
2012-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
Sponsor:
Organization:
Raw JSON
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Recombinant activated factor VII in treatment of bleeding complications following hematopoietic stem cell transplantation. J Thromb Haemost. 2005 Sep;3(9):1935-44. doi: 10.1111/j.1538-7836.2005.01523.x.'}], 'seeAlsoLinks': [{'url': 'http://novonordisk-trials.com', 'label': 'Clinical Trials at Novo Nordisk'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have undergone allogeneic or autologous stem cell transplantation\n\nExclusion Criteria:\n\n* Known or suspected allergy to trial product\n* Participation in other trials with unapproved drugs or trials with equal or similar objective'}, 'identificationModule': {'nctId': 'NCT01562158', 'briefTitle': 'Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'F7BMT-1360'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Procedure: standard therapy', 'Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose', 'interventionNames': ['Procedure: standard therapy', 'Drug: activated recombinant human factor VII']}, {'type': 'EXPERIMENTAL', 'label': 'Medium dose', 'interventionNames': ['Procedure: standard therapy', 'Drug: activated recombinant human factor VII']}, {'type': 'EXPERIMENTAL', 'label': 'High dose', 'interventionNames': ['Procedure: standard therapy', 'Drug: activated recombinant human factor VII']}], 'interventions': [{'name': 'standard therapy', 'type': 'PROCEDURE', 'description': 'Standard treatment of bleeding', 'armGroupLabels': ['High dose', 'Low dose', 'Medium dose', 'Placebo']}, {'name': 'activated recombinant human factor VII', 'type': 'DRUG', 'description': 'Two days repeated treatment regimen - low dose administered i.v. 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