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

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ClinicalTrials.gov Identifier: NCT01562821
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 13, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief 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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
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
Study Start Date : July 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. The RBC transfusion requirements

Secondary Outcome Measures :
  1. Number of transfusion product units
  2. Change in coagulation-related parameters
  3. Adverse events


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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
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

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