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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562821
First Posted: March 26, 2012
Last Update Posted: January 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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.

Condition Intervention Phase
Acquired Bleeding Disorder Cirrhosis Drug: activated recombinant human factor VII Drug: placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • The RBC transfusion requirements

Secondary Outcome Measures:
  • Number of transfusion product units
  • Change in coagulation-related parameters
  • Adverse events

Enrollment: 235
Study Start Date: July 2001
Study Completion Date: December 2002
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low dose 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
Experimental: High dose 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
Placebo Comparator: Placebo Drug: placebo
An initial placebo bolus dose followed by placebo every second hour until completion of surgery

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562821


Locations
China, Beijing
Novo Nordisk Investigational Site
Beijing, Beijing, China, 100021
China, Shanghai
Novo Nordisk Investigational Site
Shanghai, Shanghai, China, 200438
China
Novo Nordisk Investigational Site
Beijing, China
Taiwan
Novo Nordisk Investigational Site
Taipei, Taiwan, 100
Novo Nordisk Investigational Site
Taipei, Taiwan, 112
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10330
Novo Nordisk Investigational Site
Bangkok, Thailand, 10700
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562821     History of Changes
Other Study ID Numbers: F7LIVER-1313
First Submitted: March 22, 2012
First Posted: March 26, 2012
Last Update Posted: January 13, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders