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: June 23, 2014
Last verified: June 2014
  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
Endpoint Classification: Safety/Efficacy Study
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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of RBC units transfused by surgical phase [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]
  • Changes in coagulation related parameters [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: August 2001
Study Completion Date: September 2003
Primary Completion Date: September 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
Genders Eligible for Study:   Both
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
Heidelberg, Australia, 3084
Canada
London, Canada, N6A 5A5
Germany
Berlin, Germany, 13353
Spain
Barcelona, Spain, 08036
Sweden
Göteborg, Sweden, 413 45
United Kingdom
Leeds, United Kingdom, LS9 7TF
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

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: June 23, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Spain: Spanish Agency for Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 22, 2014