Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

• Status: Completed
• Trial end date: 2002-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Cirrhosis (Child-Turcotte Score A, B, or C)

• Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours

Exclusion Criteria:

• Portal vein thrombosis

• Clinically documented DVT (deep venous thrombosis)

• Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke

• Present renal insufficiency requiring dialysis