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

Primary Purpose

Acquired Bleeding Disorder, Bleeding During/Following Surgery

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
activated recombinant human factor VII
activated recombinant human factor VII
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acquired Bleeding Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High dose

Low dose

Placebo

Arm Description

Outcomes

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

Full Information

First Posted
March 22, 2012
Last Updated
January 12, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01563458
Brief Title
Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
August 2003 (Actual)
Study Completion Date
August 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Bleeding Disorder, Bleeding During/Following Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High dose
Arm Type
Experimental
Arm Title
Low dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Total number of RBC units transfused during the perioperative period
Secondary Outcome Measure Information:
Title
Number of RBC units transfused by surgical phase
Title
Adverse events
Title
Changes in coagulation related parameters

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Camperdown
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
3084
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Quebec
ZIP/Postal Code
H3H1A1
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Toronto
ZIP/Postal Code
M5G-2C4
Country
Canada
Facility Name
Novo Nordisk Investigational Site
City
Clichy
ZIP/Postal Code
92 188
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Baracaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Edinburgh
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Leeds
ZIP/Postal Code
LS9 7TS
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16035095
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 Transpl. 2005 Aug;11(8):973-9. doi: 10.1002/lt.20470.
Results Reference
result
PubMed Identifier
16734808
Citation
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):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

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

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