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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01563458
First received: March 22, 2012
Last updated: January 12, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Acquired Bleeding Disorder
Bleeding During/Following Surgery
Drug: activated recombinant human factor VII
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Total number of RBC units transfused during the perioperative period

Secondary Outcome Measures:
  • Number of RBC units transfused by surgical phase
  • Adverse events
  • Changes in coagulation related parameters

Enrollment: 208
Study Start Date: August 2001
Study Completion Date: August 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Low dose 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
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563458

Locations
Australia
Novo Nordisk Investigational Site
Camperdown, Australia, 2050
Novo Nordisk Investigational Site
Heidelberg, Australia, 3084
Canada, British Columbia
Novo Nordisk Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada
Novo Nordisk Investigational Site
London, Canada, N6A 5A5
Novo Nordisk Investigational Site
Quebec, Canada, H3H1A1
Novo Nordisk Investigational Site
Toronto, Canada, M5G-2C4
France
Novo Nordisk Investigational Site
Clichy, France, 92 188
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 13353
Novo Nordisk Investigational Site
Essen, Germany, 45122
Spain
Novo Nordisk Investigational Site
Baracaldo, Spain, 48903
Novo Nordisk Investigational Site
Barcelona, Spain, 08036
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 413 45
Novo Nordisk Investigational Site
Stockholm, Sweden, 141 86
United Kingdom
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01563458     History of Changes
Other Study ID Numbers: F7LIVER-1256 
Study First Received: March 22, 2012
Last Updated: January 12, 2017

Additional relevant MeSH terms:
Hemorrhage
Blood Coagulation Disorders
Hemostatic Disorders
Pathologic Processes
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on January 19, 2017