NCT01564563|TerminatedPhase 2

Study Stopped

Trial enrollment was prematurely terminated due to excessively slow patient recruitment

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)

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7SCT-1485

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2012

StartedJun 2002

CompletionOct 2003

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.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Jun 2002

Shorter than P25 for phase_2

Geographic Reach

1 country

7 active sites

Status

terminated

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

1.3 years study duration

Study Start

First participant enrolled

June 28, 2002

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2003

Completed

8.4 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2012

Completed

Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

1.3 years

First QC Date

March 23, 2012

Last Update Submit

February 23, 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 (4)

Transfusion requirements
Bleeding evaluation
Adverse events
Changes in safety coagulation parameters

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Drug: standard therapyDrug: placebo

Low dose

EXPERIMENTAL

Drug: standard therapyDrug: activated recombinant human factor VII

High dose

EXPERIMENTAL

Drug: standard therapyDrug: activated recombinant human factor VII

Interventions

standard therapyDRUG

Standard treatment of bleeding

High doseLow dosePlacebo

placeboDRUG

Placebo

activated recombinant human factor VIIDRUG

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

Low dose

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 a hematopoietic 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.