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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
ClinicalTrials.gov Identifier:
NCT01562821
First received: March 22, 2012
Last updated: May 22, 2012
Last verified: May 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Locations
Taiwan
Taipei, Taiwan, 100
Thailand
Bangkok, Thailand, 10330
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Peter B. Schelde Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562821     History of Changes
Other Study ID Numbers: F7LIVER-1313
Study First Received: March 22, 2012
Last Updated: May 22, 2012
Health Authority: Taiwan: Department of Health
Thailand: Food and Drug Administration

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemorrhage
Liver Cirrhosis
Fibrosis
 Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 19, 2013