NCT01564563TerminatedPhase 2
A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Effect on bleeding, defined as change in bleeding score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who have undergone a hematopoietic 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
Arms & Interventions
Low dose
Experimental
Intervention: standard therapy (Drug)
Low dose
Experimental
Intervention: activated recombinant human factor VII (Drug)
High dose
Experimental
Intervention: standard therapy (Drug)
High dose
Experimental
Intervention: activated recombinant human factor VII (Drug)
Placebo
Placebo Comparator
Intervention: standard therapy (Drug)
Placebo
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Effect on bleeding, defined as change in bleeding score
Secondary Outcomes
- Changes in safety coagulation parameters
- Transfusion requirements
- Bleeding evaluation
- Adverse events
Investigators
Study Sites (1)
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