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

Phase 2

Completed

• Conditions: Acquired Bleeding Disorder; Cirrhosis
• Interventions: Drug: activated recombinant human factor VII; Drug: placebo

• Registration Number: NCT01562821
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-07
• Primary Completion: 2002-12
• Study Completion: 2002-12
• Study First Submitted: 2012-03-22
• Study First Submitted QC: 2012-03-23
• Study First Posted: 2012-03-26
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High dose	activated recombinant human factor VII	-
Low dose	activated recombinant human factor VII	-
Placebo	placebo	-

Primary Outcome Measures

Name	Time	Method
The RBC transfusion requirements

Secondary Outcome Measures

Name	Time	Method
Change in coagulation-related parameters
Adverse events
Number of transfusion product units

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇹🇭 Bangkok, Thailand