Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Bleeding During/Following Surgery; Acquired Bleeding Disorder

Treatments: Drug: placebo; Drug: activated recombinant human factor VII; Procedure: standard therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT01562158

F7BMT-1360

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

Procedure: standard therapy

Low dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Procedure: standard therapy

Drug: activated recombinant human factor VII

Medium dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Procedure: standard therapy

Drug: activated recombinant human factor VII

High dose

Experimental group

Treatment:

Drug: activated recombinant human factor VII

Drug: activated recombinant human factor VII

Procedure: standard therapy

Drug: activated recombinant human factor VII