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

NCT01562821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 235

Last updated 2017-01-13

No results posted yet for this study

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.

Conditions

  • Acquired Bleeding Disorder
  • Cirrhosis

Interventions

DRUG

activated 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

DRUG

activated recombinant human factor VII

An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery

DRUG

placebo

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-07-31
Primary Completion
2002-12-31
Completion
2002-12-31

Countries

  • China
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01562821 on ClinicalTrials.gov