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

Acquired Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563458
• Other study ID #: F7LIVER-1256
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2012
• Last updated: January 12, 2017
• Start date: August 2001
• Est. completion date: August 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: August 2003
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Bleeding During/Following Surgery
• Blood Coagulation Disorders
• Hemorrhage
• Hemostatic Disorders

Intervention

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
• 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
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

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Camperdown
Australia	Novo Nordisk Investigational Site	Heidelberg
Canada	Novo Nordisk Investigational Site	London
Canada	Novo Nordisk Investigational Site	Quebec
Canada	Novo Nordisk Investigational Site	Toronto
Canada	Novo Nordisk Investigational Site	Vancouver	British Columbia
France	Novo Nordisk Investigational Site	Clichy
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Essen
Spain	Novo Nordisk Investigational Site	Baracaldo
Spain	Novo Nordisk Investigational Site	Barcelona
Spain	Novo Nordisk Investigational Site	Valencia
Sweden	Novo Nordisk Investigational Site	Göteborg
Sweden	Novo Nordisk Investigational Site	Stockholm
United Kingdom	Novo Nordisk Investigational Site	Birmingham
United Kingdom	Novo Nordisk Investigational Site	Edinburgh
United Kingdom	Novo Nordisk Investigational Site	Leeds
United Kingdom	Novo Nordisk Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Australia,  Canada,  France,  Germany,  Spain,  Sweden,  United Kingdom, 

References & Publications (2)

Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919 — View Citation

Lodge JP, Jonas S, Jones RM, Olausson M, Mir-Pallardo J, Soefelt S, Garcia-Valdecasas JC, McAlister V, Mirza DF; rFVIIa OLT Study Group.. Efficacy and safety of repeated perioperative doses of recombinant factor VIIa in liver transplantation. Liver Transp — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of RBC units transfused during the perioperative period
Secondary	Number of RBC units transfused by surgical phase
Secondary	Adverse events
Secondary	Changes in coagulation related parameters

External Links

•   Clinical Trials at Novo Nordisk