NCT01563458|CompletedPhase 2

Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

F7LIVER-1256

Study Type

interventional

Target

208

Locations

7 countries

Sites

Timeline

RegisteredMar 2012

StartedAug 2001

CompletionAug 2003

Brief Summary

This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

Trial Health

On Track

Trial Health Score

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

Enrollment

208

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2001

Geographic Reach

7 countries

18 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 years study duration

Study Start

First participant enrolled

August 1, 2001

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed

8.6 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed

Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

March 22, 2012

Last Update Submit

January 12, 2017

Conditions

Acquired Bleeding Disorder Bleeding During/Following Surgery

Outcome Measures

Primary Outcomes (1)

Total number of RBC units transfused during the perioperative period

Secondary Outcomes (3)

Number of RBC units transfused by surgical phase
Adverse events
Changes in coagulation related parameters

Study Arms (3)

High dose

EXPERIMENTAL

Drug: activated recombinant human factor VII

Low dose

EXPERIMENTAL

Drug: activated recombinant human factor VII

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

activated recombinant human factor VIIDRUG

120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure

High dose

placeboDRUG

Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Scheduled to undergo orthotopic liver transplantation
Liver disease classified as Child-Turcotte (Pughs modification) score B or C

You may not qualify if:

Previous liver transplantation
Scheduled multi-organ transplantation
Scheduled for living related donor transplantation
Present renal insufficiency requiring dialysis
Pregnancy

Contact the study team to confirm eligibility.