Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
NCT ID: NCT01564563
Last Updated: 2017-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
11 participants
INTERVENTIONAL
2002-06-28
2003-10-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
standard therapy
Standard treatment of bleeding
placebo
Placebo
Low dose
standard therapy
Standard treatment of bleeding
activated recombinant human factor VII
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
High dose
standard therapy
Standard treatment of bleeding
activated recombinant human factor VII
Two days repeated treatment regimen - high dose administered i.v. (into the vein)
Interventions
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standard therapy
Standard treatment of bleeding
placebo
Placebo
activated recombinant human factor VII
Two days repeated treatment regimen - low dose administered i.v. (into the vein)
activated recombinant human factor VII
Two days repeated treatment regimen - high dose administered i.v. (into the vein)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Participation in other trials with unapproved drugs or trials with equal or similar objective
12 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Little Rock, Arkansas, United States
Novo Nordisk Investigational Site
Duarte, California, United States
Novo Nordisk Investigational Site
Baltimore, Maryland, United States
Novo Nordisk Investigational Site
St Louis, Missouri, United States
Novo Nordisk Investigational Site
New York, New York, United States
Novo Nordisk Investigational Site
Chapel Hill, North Carolina, United States
Novo Nordisk Investigational Site
Houston, Texas, United States
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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F7SCT-1485
Identifier Type: -
Identifier Source: org_study_id
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