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

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)

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01564563

Enrollment

Registered

2012-03-28

Start date

2002-06-28

Completion date

2003-10-27

Last updated

2017-02-27

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 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.

Interventions

DRUGstandard therapy

Standard treatment of bleeding

DRUGplacebo

Placebo

DRUGactivated recombinant human factor VII

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

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Adverse events	—
Changes in safety coagulation parameters	—
Transfusion requirements	—
Bleeding evaluation	—

Countries

United States

Outcome results

None listed

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