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

Novo Nordisk A/S100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Acquired Bleeding Disorder Bleeding During/Following Surgery

Interventions

standard therapyPROCEDURE

Standard treatment of bleeding

activated recombinant human factor VIIDRUG

Two days repeated treatment regimen - low dose administered i.v. (into the vein)

activated recombinant human factor VIIDRUG

Two days repeated treatment regimen - medium dose administered i.v. (into the vein)

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

Effect on bleeding, defined as change in bleeding score

Secondary Outcomes

Transfusion requirements

Bleeding evaluation

Adverse events

Data from ClinicalTrials.gov

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