NCT01562158|CompletedPhase 2

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)

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7BMT-1360

Study Type

interventional

Target

100

Locations

15 countries

Sites

Timeline

RegisteredMar 2012

StartedApr 2001

CompletionOct 2003

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

100

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Apr 2001

Geographic Reach

15 countries

45 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

Study Start

First participant enrolled

April 1, 2001

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2003

Completed

8.5 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed

1 day until next milestone

First Posted

Study publicly available on registry

March 23, 2012

Completed

Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

2.5 years

First QC Date

March 22, 2012

Last Update Submit

January 10, 2017

Conditions

Acquired Bleeding Disorder Bleeding During/Following Surgery

Outcome Measures

Primary Outcomes (1)

Effect on bleeding, defined as change in bleeding score

Secondary Outcomes (3)

Transfusion requirements
Bleeding evaluation
Adverse events

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Procedure: standard therapyDrug: placebo

Low dose

EXPERIMENTAL

Procedure: standard therapyDrug: activated recombinant human factor VII

Medium dose

EXPERIMENTAL

Procedure: standard therapyDrug: activated recombinant human factor VII

High dose

EXPERIMENTAL

Procedure: standard therapyDrug: activated recombinant human factor VII

Interventions

standard therapyPROCEDURE

Standard treatment of bleeding

High doseLow doseMedium dosePlacebo

activated recombinant human factor VIIDRUG

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

Low dose

placeboDRUG

Placebo

Eligibility Criteria

Age12 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Patients who have undergone allogeneic or autologous stem cell transplantation

You may not qualify if:

Known or suspected allergy to trial product
Participation in other trials with unapproved drugs or trials with equal or similar objective

Contact the study team to confirm eligibility.