Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation
Phase 2
Terminated
- Conditions
- Bleeding During/Following SurgeryAcquired Bleeding Disorder
- Interventions
- Drug: standard therapyDrug: activated recombinant human factor VIIDrug: placebo
- Registration Number
- NCT01564563
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 11
Inclusion Criteria
- Patients who have undergone a hematopoietic stem cell transplantation
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Exclusion Criteria
- Known or suspected allergy to trial product
- Participation in other trials with unapproved drugs or trials with equal or similar objective
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo standard therapy - High dose standard therapy - Low dose activated recombinant human factor VII - Placebo placebo - High dose activated recombinant human factor VII - Low dose standard therapy -
- Primary Outcome Measures
Name Time Method Effect on bleeding, defined as change in bleeding score
- Secondary Outcome Measures
Name Time Method Changes in safety coagulation parameters Transfusion requirements Bleeding evaluation Adverse events
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇺🇸Houston, Texas, United States