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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:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01562821
First received: March 22, 2012
Last updated: October 28, 2013
Last verified: October 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of transfusion product units [ Designated as safety issue: No ]
  • Change in coagulation-related parameters [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01562821

Locations
China, Beijing
Beijing, Beijing, China, 100021
Taiwan
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10330
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Peter B. Schelde Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT01562821     History of Changes
Other Study ID Numbers: F7LIVER-1313
Study First Received: March 22, 2012
Last Updated: October 28, 2013
Health Authority: Taiwan: Department of Health
Thailand: Food and Drug Administration
China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014