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

A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562158

Enrollment

100

Registered

2012-03-23

Start date

2001-04-30

Completion date

2003-10-31

Last updated

2017-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Bleeding During/Following Surgery

Brief summary

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.

Interventions

PROCEDUREstandard therapy

Standard treatment of bleeding

DRUGactivated recombinant human factor VII

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

DRUGplacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Effect on bleeding, defined as change in bleeding score	—

Secondary

Measure	Time frame
Transfusion requirements	—
Bleeding evaluation	—
Adverse events	—

Countries

Australia, Austria, Denmark, Finland, France, Germany, Israel, Italy, Poland, Singapore, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026