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

Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562821
• Other study ID #: F7LIVER-1313
• Status: Completed
• Phase: Phase 2
• First received: March 22, 2012
• Last updated: January 12, 2017
• Start date: July 2001
• Est. completion date: December 2002

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 2002
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Bleeding Disorder
• Blood Coagulation Disorders
• Cirrhosis
• Hemostatic Disorders

Intervention

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

Locations

Country	Name	City	State
China	Novo Nordisk Investigational Site	Beijing
China	Novo Nordisk Investigational Site	Beijing	Beijing
China	Novo Nordisk Investigational Site	Shanghai	Shanghai
Taiwan	Novo Nordisk Investigational Site	Taipei
Taiwan	Novo Nordisk Investigational Site	Taipei
Thailand	Novo Nordisk Investigational Site	Bangkok
Thailand	Novo Nordisk Investigational Site	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

China,  Taiwan,  Thailand, 

References & Publications (2)

Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919 — View Citation

Shao YF, Yang JM, Chau GY, Sirivatanauksorn Y, Zhong SX, Erhardtsen E, Nivatvongs S, Lee PH. Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, pl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The RBC transfusion requirements
Secondary	Number of transfusion product units
Secondary	Change in coagulation-related parameters
Secondary	Adverse events

External Links

•   Clinical Trials at Novo Nordisk