Overview

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

Status:
Completed
Trial end date:
2003-08-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
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