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OpenTrials
Completed

NCT Number: NCT01562821

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

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.

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Key information

Conditions

Acquired Bleeding Disorder Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novo Nordisk Investigational Site, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

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

Placebo

Drug

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

Primary outcomes

  1. The RBC transfusion requirements

Secondary outcomes

  1. Number of transfusion product units

  2. Change in coagulation-related parameters

  3. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
Mar 26, 2012
Registry last updated
Jan 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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