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

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01562821

Enrollment

235

Registered

2012-03-26

Start date

2001-07-31

Completion date

2002-12-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acquired Bleeding Disorder, Cirrhosis

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.

Interventions

DRUGactivated recombinant human factor VII

An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery

DRUGplacebo

An initial placebo bolus dose followed by placebo every second hour until completion of surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The RBC transfusion requirements	—

Secondary

Measure	Time frame
Number of transfusion product units	—
Change in coagulation-related parameters	—
Adverse events	—

Countries

China, Taiwan, Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026