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

January 12, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

208

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Camperdown, Australia, 2050
        • Novo Nordisk Investigational Site
      • Heidelberg, Australia, 3084
        • Novo Nordisk Investigational Site
  • Canada
      • London, Canada, N6A 5A5
        • Novo Nordisk Investigational Site
      • Quebec, Canada, H3H1A1
        • Novo Nordisk Investigational Site
      • Toronto, Canada, M5G-2C4
        • Novo Nordisk Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Novo Nordisk Investigational Site
  • France
      • Clichy, France, 92 188
        • Novo Nordisk Investigational Site
  • Germany
      • Berlin, Germany, 13353
        • Novo Nordisk Investigational Site
      • Essen, Germany, 45122
        • Novo Nordisk Investigational Site
  • Spain
      • Baracaldo, Spain, 48903
        • Novo Nordisk Investigational Site
      • Barcelona, Spain, 08036
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Sweden
      • Göteborg, Sweden, 413 45
        • Novo Nordisk Investigational Site
      • Stockholm, Sweden, 141 86
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • Edinburgh, United Kingdom
        • Novo Nordisk Investigational Site
      • Leeds, United Kingdom, LS9 7TS
        • Novo Nordisk Investigational Site
      • London, United Kingdom, SE5 9RS
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
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
Experimental: Low dose
Drug: activated recombinant human factor VII
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
Drug: activated recombinant human factor VII
60 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. 60 mcg/kg single bolus administration at completion of wound closure
Experimental: High dose
Drug: activated recombinant human factor VII
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
Drug: activated recombinant human factor VII
60 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. 60 mcg/kg single bolus administration at completion of wound closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Total number of RBC units transfused during the perioperative period

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

August 1, 2003

Study Completion (Actual)

August 1, 2003

Study Registration Dates

First Submitted

March 22, 2012

First Submitted That Met QC Criteria

March 23, 2012

First Posted (Estimate)

March 27, 2012

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F7LIVER-1256

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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